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Senior Automation Engineer Jobs At Johnson & Johnson

- 338 Jobs
  • Quality Assurance Engineer

    Onkos Surgical 3.9company rating

    Parsippany-Troy Hills, NJ Jobs

    The Quality Assurance (QA) Engineer II will play a key role in the implementation of Onkos Surgical's Quality Management System and have the opportunity to gain experience across a broad range of quality functions related ISO 13485 and 21 CFR Part 820 compliance. Specifically, the QA Engineer will champion complaint handling, product release procedures and approval, and support to both NCR and CAPA processes. This will require developing relationships and working closely with suppliers. This position will also work with cross-functional teams to provide quality engineering support in the development of technical files to ensure regulatory compliance during product development. Responsibilities Receive, document and process complaints related to product quality and patient safety. Conduct, coordinate and document complaint investigations. Review complaints for possible Adverse Events/MDRs and recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner to meet regulatory deadlines. Review and approve Device History Records (DHRs) and communicate closely with contract suppliers to ensure compliance with Quality Agreements and QMS procedures. Participate in and support NCR and CAPA investigations. Participate in the application of statistical methods to trend NCRs, CAPAs, Complaints, and DHR approval acceptance. Support in Supplier vetting process and maintaining Approved Supplier List. Provide support to Product Development and Operations on design transfer and process validations. Participate in product risk assessment efforts, including failure mode effect analysis (FMEA's). Monitor quality metrics and key process indicators to identify opportunities. Lead and/or participate in multi-departmental initiatives to implement quality improvements. Drive compliance to the QMS and provide QMS training to appropriate team members. Author changes to existing procedures, work instructions, and forms as necessary. Comply with U.S. FDA and ISO requirements, other regulatory requirements, Company policies, operating procedures and processes. Perform other QA and quality control functions as necessary, with appropriate training. Assist in the review of Technical Files. Requirements Minimum of 5 years quality assurance experience in medical device industry. Manufacturing or supplier quality engineering experiences a plus. Working knowledge of CFR Part 820 and 13485 for medical device products. Complaint investigation experience. BS in an engineering discipline. Certified Quality Engineer certification a plus. Experience in root cause failure analysis and change control. Detail oriented and experience in a manufacturing environment a plus. Good verbal (including presentation) and written communication skills. About Onkos Surgical At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will: Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.
    $75k-106k yearly est. 3d ago
  • Software Engineering Lead (Full Stack)

    Eurofins USA Environment Testing 4.4company rating

    Strongsville, OH Jobs

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description Are you ready to lead, design, and build next-generation cloud applications? Apply now and be a key part of our engineering journey Eurofins TestOil is looking for a highly skilled and motivated Software Engineering Lead to join our growing digital technology team. This hybrid role combines hands-on coding, architectural ownership, and people leadership. The ideal candidate is a full stack engineer with a proven track record in designing REST APIs, cloud-native solutions, and leading development teams in Azure environments. This role will be structured as: 50% Hands-On Development 30% Architecture & System Design 20% Team Leadership & Management Key Responsibilities: Hands-On Engineering (50%) Design, develop, and maintain scalable full stack applications using modern web technologies. Lead by example in writing clean, maintainable, and testable code. Conduct code reviews. Architecture & Design (30%) Define and oversee architectural decisions and technical standards. Design cloud-native solutions leveraging Azure services. Collaborate with stakeholders to translate business requirements into technical solutions. Leadership & Management (20%) Provide technical guidance and leadership to a small team of engineers. Assist in sprint planning, task estimation, and team performance reviews. Champion engineering excellence, team collaboration and continuous improvement. Qualifications 5+ years of professional software development experience, with a strong background in full stack development. Proficiency in modern front-end (e.g., React) and back-end technologies (e.g., .NET Core). Strong experience designing, developing, and maintaining RESTful APIs. Solid experience with Azure DevOps for CI/CD pipelines, version control (Git), and work tracking. Proficient with SQL and working with relational databases (e.g., SQL Server, PostgreSQL, or MySQL), including query optimization and database design. Deep understanding of Azure Cloud Services (e.g., App Services, Application Gateway, Key Vault, Storage). Experience designing and implementing scalable, secure, and high-performance systems. Excellent problem-solving skills and the ability to communicate complex technical concepts to non-technical stakeholders. Prior experience mentoring or leading small teams is a plus. Preferred Qualifications: Azure certifications (e.g., Azure Developer Associate, Azure Solutions Architect). Experience with infrastructure as code (e.g., ARM templates). Familiarity with containerization technologies (e.g., Docker, Kubernetes on Azure AKS). Additional Information Position is a FT, onsite position on the 1st shift. What We Offer: Competitive salary and benefits package. Opportunity to shape the architecture and engineering culture of a fast-growing team. Continuous learning opportunities and support for certification/training. Are you ready to lead, design, and build next-generation cloud applications? Apply now and be a key part of our engineering journey! Benefits: 401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance To learn more about Eurofins, please explore our website ******************* We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $95k-127k yearly est. 5d ago
  • Lead Software Engineer

    Allergan Aesthetics 4.8company rating

    Salt Lake City, UT Jobs

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit *************************************** Follow Allergan Aesthetics on LinkedIn. Allergan Aesthetics | An AbbVie Company Job Description We're looking for a Lead Engineer interested in working within a startup-oriented environment while having the backing of a very large company. If that's you, please read on. As the Lead Engineer, you will report to the Software Engineering Manager and continuously collaborate with key stakeholders across the business to solve the most critical technical problems. You Will Champion code quality, reusability, scalability security and strategic software architecture decisions Mentor software engineers utilizing code reviews, proven design patterns and your experience building large scale public facing software Collaborate with Product and Project Management to take small ideas or concepts and turn them into high fidelity technical game plans and achieve the products and business goals Care about who you work with and how work is done. We hire carefully and the entire team is given the opportunity to take part in evaluating potential hires Relate to our core values (see below) and would like to contribute to a positive working environment and culture Qualifications At least 8+ years as a Full Stack Software Engineer and 4+ years experience leading engineering teams. Adept at drafting, validating and implementing software systems architecture using modern development and deployment technologies and can speak thoroughly to their tradeoffs. Experience organizing and prioritizing tasks with Product and Project Management for a team of 4+ Engineers Strong Experience with TypeScript/JavaScript, React, NextJS, and React Native (bonus) Experience working with a CMS (bonus Contentful) Strong familiarity with data structures, algorithms and design patterns Proponent of code testing and familiar with the common frameworks for unit, integration and functional tests Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $108k-143k yearly est. 15d ago
  • Senior Software Engineer

    Contract Pharmacal Corp 4.3company rating

    Hauppauge, NY Jobs

    Job DescriptionDescription: The Senior Software Engineer is responsible for developing software to deliver high-quality, innovative software solutions for CPC’s e-commerce platforms, in-house ERP design & implementation, and blockchain technology. This role involves full-stack development, blockchain integration, DevOps, and leading best practices in software architecture and engineering. Responsibilities: include but are not limited to - Develop and maintain responsive UIs using React, TypeScript, and Material UI, ensuring seamless integration with backend services and a strong user experience. Collaborate with designers and marketing teams on UI/UX improvements, SEO-driven content, and website maintenance, including regular updates to themes and plugins. Design, develop, and optimize RESTful APIs and microservices using Node.js, NestJS, PostgreSQL, and Prisma ORM, ensuring data integrity and scalability. Manage the design, implementation, and maintenance of the in-house ERP system and e-commerce platforms, supporting business operations and integrations. Oversee the company’s blockchain and NFT program, ensuring secure implementation and best practices in cryptographic protocols. Work with Ethereum and Layer 2 solutions, integrating smart contracts and blockchain technologies using Solidity, Ethers.js, and Web3.js. Implement and maintain CI/CD pipelines and containerized applications with Docker to streamline deployments and system reliability. Develop and enforce software development best practices, including unit/integration testing, coding standards, and version control. Troubleshoot and resolve stack-wide performance, security, and functionality issues. Work closely with key stakeholders to translate business requirements into scalable technical solutions, aligning development with company objectives. Stay up to date with emerging technologies and industry trends, incorporating advancements into system architecture and business operations. Provide strategic recommendations and scope for new site developments, feature enhancements, and infrastructure improvements. Other projects and duties as assigned by senior management. Requirements: Education and Experience: Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field. 5+ years of experience as a Full-Stack developer; experience leading and managing a team preferred. Strong expertise in TypeScript, JavaScript, React, Node.js, NestJS, PostgreSQL, and Prisma ORM. Hands-on experience integrating blockchain technologies, smart contracts, and cryptographic protocols. Experience with Docker, CI/CD pipelines, and Agile methodologies. Strong track record of delivering high-quality software solutions on time and on budget. Skills, Abilities, and Knowledge: Knowledge of other blockchain platforms (e.g., Solana, Polkadot). Experience in mobile development, WebSockets, or image processing. Knowledge of e-commerce systems such as payment gateways, shopping cart systems, and CRM systems. Excellent communication and leadership skills, with the ability to work effectively in a team environment. Strong analytical, reasoning and problem-solving skills. Ability to translate and summarize complex data into understandable, actionable information and recommendations. Ability to prioritize assignments and meet deadlines in a fast-paced and growth-oriented environment. Physical Demands: Required to use hands to operate computer controls. Specific vision abilities required include close vision, ability to focus. While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear or walk for long periods. The employee may lift and/or move up to 50 lbs. Work Environment: Employee travel/work hours/schedule/location and/or shift are subject to change based on business needs and Management discretion. Potential to move between production operation sites/areas to complete job functions. Work locations are subject to change as needed to meet business requirements. Supervisory Responsibilities: May be responsible for managing IT employees. Personal Protective Equipment or Attire Required for Position: Gowning as required by GMPs and/or SOPs. Pay Range: $180,000 - $215,000 per year
    $180k-215k yearly 18d ago
  • Senior Software Engineer

    Allergan Aesthetics 4.8company rating

    Irvine, CA Jobs

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit *************************************** Follow Allergan Aesthetics on LinkedIn. Allergan Aesthetics | An AbbVie Company Job Description Are you a passionate Senior Software Engineer ready to take on the exciting challenge of building critical core foundational platforms that empower our internal application teams? If this thrilling opportunity calls to you, read on! As the Senior Software Engineer, you will report to the Software Engineering Manager and continuously collaborate with key stakeholders across the business to solve the most critical technical problems. You Will Own and deliver projects that may span multiple sprints Independently identify the right solutions to solve ambiguous, open-ended problems May own several small components/services Collaborative Reach - Work primarily with direct team and cross-functional partners while driving cross-team collaboration for my project Project Leadership - Define and deliver well-scoped milestones for a project. Product Expertise - Leverage input from product stakeholders as available to determine the right technical solutions Mentorship - Actively level up less-experienced members of team utilizing code reviews, proven design patterns and your experience building large scale public facing software Champion code quality, reusability, scalability security and strategic software architecture decisions Care about who you work with and how work is done. We hire carefully and the entire team is given the opportunity to take part in evaluating potential hires Relate to our core values (see below) and would like to contribute to a positive working environment and culture Code fluency Write code that captures the essential nature of the solution and is appropriately flexible, reusable, efficient, and adaptable to changing requirements. Ensure high code quality in code reviews. Strong awareness of the ecosystem of tools and libraries supporting the primary programming language and development environment and a strong grasp of the idioms and patterns of language. May be intimately familiar with the open source community surrounding it. Software design Able to independently design software components in well scoped scenarios, with simplicity and maintenance as key considerations. Components are testable, debuggable and have logical APIs that are not easily misused. Demonstrates good judgment as to when to make significant refactors and when it’s better to leave things as-is. Strong grasp of dependent libraries, platforms, and systems, ability to expertly leverage them Understanding of more advanced software patterns and the ability to apply them appropriately during implementation. Qualifications At least 6+ years as a Full Stack Software Engineer and bonus to have experience leading other developers. Strong experience with TypeScript/JavaScript, Node.js, and GraphQL Experience with Microservices and Event Driven Architecture using AWS, Serverless, Lambda, Docker, and Kubernetes Strong familiarity with data structures, algorithms and design patterns Proficient with PostgreSQL, DynamoDB and understand when to use relational and non-relational databases. Proponent of code testing and familiar with the common frameworks for unit, integration and functional tests Experience working with DevOps Engineers using tools such as Terraform, CloudFormation, and CI/CD Pipelines. Adept at drafting, validating and implementing software systems architecture using modern development and deployment technologies and can speak thoroughly to their tradeoffs. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $123k-155k yearly est. 5d ago
  • Senior Software Engineer

    Diality Inc. 3.9company rating

    Irvine, CA Jobs

    Job Description Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems. The Senior Software Engineer will be responsible for designing, developing, testing, and maintaining embedded software, and related tools for our medical devices. This role requires effective collaboration with cross-functional team members including systems, hardware, regulatory, and clinical staff to ensure the software aligns with product requirements and complies with safety, performance, and usability standards. Responsibilities: Design, implement, debug, and test embedded software for Class B and Class C medical devices using C/C++ and Python. Deliver high-quality, testable, and maintainable code that meets functional, performance, and safety requirements. Ensure embedded software design robustness through unit testing, static analysis, code reviews, and integration testing. Work closely with electrical, mechanical, systems, and software teams to define embedded software interfaces and system-level behaviors. Support board bring-up, device integration, and hardware-software co-design activities. Participate in software development within a Hybrid Agile-V model, contributing to sprint planning, grooming, reviews, and retrospectives. Create and maintain requirements, design, implementation, and verification documentation in accordance with FDA regulations and IEC 62304 standard. Operate effectively both independently and as a collaborative team member in a fast-paced, dynamic development environment. Required Skills & Abilities Proficient in embedded C/C++ programming with working knowledge of Python for scripting test and automation tasks. Solid understanding of real-time operating systems (RTOS), interrupt handling, memory management, and hardware abstraction. Skilled in device driver development. The ability to read and interpret hardware data sheets and schematics is a plus. Expertise in debugging and troubleshooting, using tools such as debuggers, oscilloscopes, logic analyzers, and JTAG/SWD interfaces. Familiarity with closed-loop control and PID algorithms is a plus. Strong knowledge of software engineering principles including modular design, version control (e.g., Git), and continuous integration workflows. Familiarity with Agile development practices and hybrid Agile/V-Model processes. Excellent written and verbal communication skills, with the ability to produce clear technical documentation and collaborate across multidisciplinary teams. Self-motivated and adaptable with proven ability to work independently and as part of a team in a dynamic, fast-paced environment. Education & Experience: Bachelor’s or Master’s degree in Computer Science, Electrical Engineering, or a related field. 5+ years of professional software development experience, preferably in the medical device or regulated industry. Experience developing embedded software for microcontroller-based systems (e.g., STM32, NXP, TI) and working with communication protocols such as UART, SPI, I2C, and CAN. Experience with unit testing, static analysis, code reviews, and system integration testing in a structured SDLC environment. Practical experience developing and documenting embedded software for FDA-regulated Class B and Class C medical device software. Working knowledge of relevant standards including IEC 62304 (software life cycle), ISO 14971 (risk management), and FDA medical device software guidance. Physical Requirements Sustained periods of time standing and sitting in a laboratory Sitting at a desk utilizing a computer Some lifting of Travel: Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.
    $119k-167k yearly est. 6d ago
  • AI/Software Engineer - SME

    Red Rock Government Services 3.7company rating

    Herndon, VA Jobs

    Job Description Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is currently seeking a seasoned Lead BERT AI & Elasticsearch Integration Specialist (AI/Software Engineer - SME) to steer the integration of BERT AI tools and Elasticsearch into our AWS cloud environment. This pivotal role is instrumental in bridging the gap between stakeholder expectations and development realities, ensuring the seamless deployment and functionality of our machine learning and AI frameworks on the cloud. Key Responsibilities: Spearhead the integration of BERT AI tools into our AWS cloud infrastructure, ensuring the robustness and effectiveness of the deployed solutions. Liaise with stakeholders to gather requirements, set integration goals, and communicate progress, challenges, and outcomes. Engage with the development team, providing guidance, support, and direction throughout the integration process. Get hands-on with AWS cloud technologies, API construction, and search technologies, ensuring optimal performance and alignment with organizational objectives. Conduct technical reviews, ensuring all integration steps adhere to best practices and standards. Facilitate knowledge transfer sessions, up skilling the team on BERT AI tools and AWS cloud technologies. Requirements: Bachelor's degree in computer science, Engineering, or related field. Proficient in AWS cloud technologies, with a strong grasp of API construction and search technologies. Prior experience with BERT AI tools and machine learning platforms is highly desirable. Experience with large text datasets as well as creating synthetic data files is preferred Demonstrated leadership experience, ideally in a cloud integration or development lead role. Ability to work independently with excellent communication and stakeholder engagement skills. Strong and proactive problem-solving and analytical abilities. Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.
    $77k-107k yearly est. 21d ago
  • Software Engineer with active FSP required

    Red Rock Government Services 3.7company rating

    McLean, VA Jobs

    Job Description Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. At Red Rock, our DevOps Software Engineers champion state-of-the-art IT solutions by collaborating closely with cross-functional teams and actively sharing knowledge gained. We specialize in facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in our DevOps Software Engineers, encouraging them to tackle new challenges with vigor. We strongly believe that fostering diversity of perspectives, ideas, and cultures is integral to our success in creating superior products. By embracing varied backgrounds and insights, we enhance innovation and achieve excellence in our endeavors. Required Qualifications: Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting BS/BA in Computer Science OR equivalent combination of education and experience Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch. Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123
    $77k-107k yearly est. 13d ago
  • Software Engineer with active FSP required

    Red Rock Government Services 3.7company rating

    Chantilly, VA Jobs

    Job Description Red Rock Government Services is a leading software engineering company recognized for its exceptional support to the intelligence community. With a proven track record of delivering innovative and mission-critical solutions, Red Rock specializes in developing secure, scalable, and cutting-edge technologies tailored to meet the complex needs of intelligence operations. The company's expertise in advanced analytics, cloud computing, and artificial intelligence enables it to empower agencies with enhanced decision-making capabilities and operational efficiency. Red Rock's commitment to excellence, agility, and collaboration solidifies its reputation as a trusted partner in safeguarding national security and advancing intelligence objectives. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is currently seeking a DevOps Software Engineer to join our team of diverse and qualified professionals. In this role, you will play a key part in advancing our mission of delivering cutting-edge language training to ensure proficiency across a wide range of languages for the Sponsor's employees. DevOps Software Engineers contribute to the development of state-of-the-art IT solutions, working closely with cross-functional teams and sharing valuable insights and lessons learned. The role emphasizes facilitating container deployments and implementing serverless architectures within AWS. We value versatility and enthusiasm in tackling new challenges. At RedRock, we believe that hiring exceptional talent and fostering diversity of perspectives, ideas, and cultures are essential to creating superior products. Requirements: BS/BA in Computer Science OR equivalent combination of education and experience Object Oriented Programming experience. Experience with AWS (e.g., CloudFormation, EC2, Lambda, DynamoDB, and ElasticSearch) Experience with relational databases (e.g., RDS, Oracle, Postgres) Experience in continuous integration technology (e.g., Chef, Puppet, Docker, Jenkins, Ansible) Experience with interacting in a Linux environment (ex - Bash scripting) Desired Qualifications: Experience with Java, JavaScript, Python, Ruby Experience with application platforms such as Spring Boot or Angular Experience with log analytics tools such as Splunk or ElasticSearch Experience working with containers using Docker. Experience with container orchestration systems such as Kubernetes and Mesos Experience in communicating with users, technical teams, and senior management. Comfortable working in a fast-paced environment Comfortable managing competing priorities and are able to bring order to ambiguous scenarios. Familiarity with Source code management and integration (ex - GitHub/GitLab) Experience in an Agile environment (JIRA, Confluence) Location: Chantilly, VA Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. VA Red Rock is an Equal Opportunity Employer. We are always searching for strong technical talent to help us serve our DoD and IC customers around the Washington, DC metro area. We are constantly in need of developers, designers, architects, engineers, QA/testers, cyber security specialists and more . CJ123
    $77k-107k yearly est. 12d ago
  • Software Engineer

    Red Rock Government Services 3.7company rating

    Chantilly, VA Jobs

    Job Description Red Rock Government Services - Discover a company you'll love to work for... Red Rock Government Services is a Woman-owned Small Business consultancy providing strategic, IT, financial, and management consulting services to the federal government within the national security environment. We are mission-focused in creating value for our customers and people-focused in providing fulfilling career and growth opportunities for our employees. We offer a generous compensation package with employee incentives, above industry-standard benefits, and a strong focus on work-life balance. This position requires a current and active TS/SCI with Full Scope Polygraph security clearance. This position does not have the ability to sponsor candidates for clearance processing. RedRock is actively seeking a proficient Software Developer specializing in independent work within a dynamic Agile scrum software development environment. The ideal candidate will possess extensive experience in utilizing agile development tools and methodologies to foster collaboration within Agile team frameworks. Required Skills: Proficiency in developing and maintaining applications using: Angular Node.js JavaScript Bootstrap or Material Design Browser technologies (HTML, HTTP, CSS) Elasticsearch ELK stack AWS (desired) MongoDB (desired) Cypress (desired) Experience with key tools and platforms: JIRA for maintaining stories and tasks. Confluence for collaboration Unit testing methodologies GitHub for version control Jenkins (desired) for automation Familiarity with: DevOps practices, build automation, and continuous integration (desired) Strong skills in: Participating in daily stand-ups Engaging in technical discussions, forums, and retrospectives Contributing to routine customer meetings and ad hoc sessions Pay and Benefits: Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Paid Leave and Retirement. Commitment to Diversity: All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law.
    $77k-107k yearly est. 31d ago
  • QA (Quality Assurance) Engineer

    Pantherx Specialty LLC 3.9company rating

    Pittsburgh, PA Jobs

    7,000 Diseases - 500 Treatments - 1 Rare Pharmacy PANTHERx is the nation's largest rare disease pharmacy, and we put the patient experience at the top of everything that we do. If you are looking for a career in the healthcare field that embraces authentic dedication to patient care, you don't need to look beyond PANTHERx. In every line of service, in every position and area of expertise, PANTHERx associates are driven to provide the highest quality outcomes for our patients. We are seeking team members who: Are inspired and compassionate problem solvers; Produce high quality work; Thrive in the excitement of the ever-challenging environment of modern medicine; and Are committed to achieving superior health outcomes for people living with rare and devastating diseases. At PANTHERx, we know our employees are the driving force in what we do. We cultivate talent and encourage growth within PANTHERx so that our associates can continue to explore their interests and expand their careers. Guided by our mission to provide uncompromising quality every day, we continue our strategic growth to further reach those affected by rare diseases. Join the PANTHERx team, and define your own RxARE future in healthcare! Location: Pittsburgh, PA; Hybrid Classification: Exempt Status: Full-time Reports to: Manager, Quality Assurance Business Purpose: The Quality Assurance (QA) Engineer designs and executes test plans to ensure the highest quality software products for our specialty pharmacy customers. This position evangelizes and executes QA policies and procedures, adhering to QA standards, and monitoring the QA process to ensure a high quality of deliverables. Responsibilities: Develops test plans and executes test cases based on business requirements. Tests across multiple platforms and applications on mobile and desktop. Monitors the QA process to ensure the highest quality of deliverables. Follows comprehensive QA processes and procedures. Analyzes and evaluates QA results. Provides a QA perspective during team meetings and scrum ceremonies. Writes SQL queries to set up and validate test data. Communicates QA results to stakeholders. Develops and implements automated testing for desktop and mobile web, native applications, and desktop applications. Required Qualifications: Bachelor's degree in computer science, Information Technology, or a related field. 2+ years of experience in software quality assurance. Knowledge of software testing processes and methodology. Excellent problem-solving and troubleshooting skills. Excellent verbal and written communication skills. Preferred Qualifications: 2 years of experience in a software QA role. 2 years of experience testing desktop and mobile web and native applications. Experience testing SMS. Experience in the pharmacy industry Experience using proprietary project and issue tracking software (Azure DevOps, JIRA, etc.). Experience using test management systems (Azure Test Plans, TestRail, etc.) Experience in developing and implementing automated testing using a scripting language (C# preferred) and Selenium. Experience automating Windows based applications using tools like AutoIt and WinAppDriver is a plus. Work Environment: PANTHERx Rare Pharmacy offers flexibility only to eligible employees to work hybrid or remotely without compromising work performance, productivity, or team collaboration. This role routinely uses standard office equipment such as computers and phones. Physical Demands: While performing the duties of this job, the employee is regularly required to talk, hear, and see. The employee frequently is required to sit, stand, and walk; use hands and fingers, handle or feel; reach with hands and arms and see a computer screen for extended periods. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of the job. Benefits: Hybrid, remote and flexible on-site work schedules are available, based on the position. PANTHERx Rare Pharmacy also affords an excellent benefit package, including but not limited to medical, dental, vision, health savings and flexible spending accounts, 401K with employer matching, employer-paid life insurance and short/long term disability coverage, and an Employee Assistance Program! Generous paid time off is also available to all full-time employees, as well as limited paid time off for part-time employees. Of course we offer paid holidays too! Equal Opportunity: PANTHERx Rare Pharmacy is an equal opportunity employer, and does not discriminate in recruiting, hiring, promotions or any term or condition of employment based on race, age, religion, gender, ethnicity, sexual orientation, gender identity, disability, protected veteran's status, or any other characteristic protected by federal, state or local laws.
    $69k-97k yearly est. 3d ago
  • Software Quality Assurance (QA) Test Engineer

    Medpace 4.5company rating

    Cincinnati, OH Jobs

    Voted a Top Cincinnati Workplace for 4 years running, Medpace is growing rapidly, and we are currently seeking a full-time, office-based Software QA Engineer to join our Information Technology (IT) team. The Medpace IT department creates custom software solutions for our internal and external business users. The Software QA Engineer is responsible for the planning and execution of software testing for one or more of these web-based applications. They will work with developers and end users to understand requirements and write test plans, execute manual and automated tests, and create summary reports. Responsibilities * Review and analyze functional requirements specifications to provide feedback and ensure requirements are testable; * Create test plans and test cases per documented requirements; * Participate in constructive peer review of test cases; * Execute functional test cases to ensure the system is robust and fit for purpose; * Report defects and work with the development team toward resolution of the defects; * Write test summary reports; * Help facilitate execution of acceptance test scripts by end users; * Attend regular project meetings (daily stand-ups, refinement meetings, etc.); and * Work closely with developers and end users throughout the software life cycle to ensure that applications meet the needs of the users. Qualifications * Bachelor's degree and 1+ years of experience in software testing, preferably in an agile-like environment; * Experience writing and executing manual testing for complex software applications; * Experience communicating and working within cross-departmental teams consisting of software developers, department leads, and end users; * Excellent computer skills; * Excellent analytical thinking skills; * Excellent written, and oral communication skills; and * Experince in the regulated healthcare industry is a plus! Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $67k-92k yearly est. 60d+ ago
  • Quality Assurance Manager/Team Leader

    Zoetis 4.9company rating

    Atlanta, GA Jobs

    What's it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose ‘to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles. We're a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we're excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios. We are currently searching for a Quality Assurance Manager to join our team. Summary The QA Manager is accountable for ensuring cGMP compliance within the site's initial mAbs Bio-packaging Operations and future Biological and Pharmaceutical Operations and is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives. Primary responsibilities include assistance with area batch record reviews and applicable product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site's compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of mAbs/ABI/BPM/Pharmaceutical manufacturing, and all Bio-packaging Operations within Zoetis Atlanta Operations. This position will initially support the Atlanta Project design, installation, qualification, validation, and registration of mAbs Bio-packaging Operations, and will ultimately lead a team of compliance specialists and OTE colleagues, supporting all future site manufacturing and packaging activities. This individual will assume a leadership role in Quality Operations, working with internal and external groups, independently prioritizing areas of quality concern and addressing with limited manager intervention. The role requires an ability to organize resources and address complex quality decisions independently and efficiently; communicate effectively and decisively with manufacturing team members as well as members of site management; and work with a team to meet site objectives. The QA Manager/TL will also interface directly with regulatory agency, customers, and internal auditors, provide support for market action activities, and will assist in the identification and communication site and department metrics. Position Responsibilities Provide QA leadership and support for product process validation activities for mAbs/ABI/BPM/Pharmaceutical and Bio-packaging Operations. Ensure cGMP compliance within the Biological and Pharmaceutical Operations systems. Interpret and enforce FDA, USDA, EMA, and other regulatory guidelines. Provides guidance and support within cGMP systems for site colleagues. Support regulatory agency, customer, and internal audits. Review and approval of action items / commitment tracking items. Review and approval of investigation and interim reports. Support market action activities. Oversee internal audits. Participate in change management activities. Assist in the review and assessment of Zoetis Quality Standards (ZQS). Collect and communication of site and department metrics. Maintain department Standard Operating Procedures (SOPs). Other responsibilities as assigned. Management Oversight Regulatory/GMP Inspections Manufacturing Support Batch Record Review Incoming Packaging Material Inspection and Intermediate Product Release Deviation investigations Change Management Activities Education and Experience B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. 3+ years of supervisory experience preferred. Technical Skills and Competencies Required Minimum Qualifications: Risk Management Investigation and Problem Solving Demonstrated technical capabilities. Ability to establish appropriate timelines to meet key milestones under minimal supervision. Deep knowledge of local, federal, and international regulations Knowledge of human error awareness / prevention Organization skills Verbal and written communication skills (fluent in English) Works effectively in a team-based environment Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines. Proficient in Microsoft Office applications Attention to detail. Demonstrated ability to work with internal and external colleagues. 6-sigma, lean or statistical skills Preferred Qualifications: Previous experience with methods in biologicals and/or pharmaceutical manufacturing and packaging Demonstrated knowledge of the Deviation (Trackwise), Change Control (Trackwise), ValGenesis, ERP (SAP), and Laboratory Information Management (LIMS) systems. Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs. Previous experience with batch record review, process deviation investigations, and change control. Physical Position Requirements Lift materials up to 40lbs Ability to sit, stand and walk Some travel may be required Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $91k-111k yearly est. 33d ago
  • Quality Assurance Team Lead - 2nd Shift

    Amneal Pharmaceuticals, Inc. 4.6company rating

    Piscataway, NJ Jobs

    The Group Leader, QA will lead, schedule and coordinate daily priorities for incoming raw materials sampling, release, reject, hold and inspection/in process QA Support/Packaging/Auditing activities in manufacturing and packaging areas. The group leader QA will train, coach and mentor QA Inspectors / Auditors on regular QA sampling, Room/ Equipment / batch release processes for training purposes. He/she will monitor and ensure all phases of drug manufacturing are in compliance with established specifications. Will ensure quality compliance before, during and after each manufacturing and packaging run. Will review production batch reviews for manufacturing and packaging work orders and determine batch disposition. Essential Functions: * All requirements of QA Inspector III and QA Auditor II, in addition to assisting the supervisor in maintaining documentation and training for QA inspectors and auditors as well as maintaining the area training matrix * Will review annual Stability Check Lot Program, hold reconcile NOI batches in JD Edwards, annual cleaning validation cleaning program tracking * Will assist prioritizing and completing reviews of manufacturing records and packaging orders in a timely manner. * Will be involve in business critical sample submissions and tracking to respective labs. * Will be responsible in data collection for closure of investigations, assessments, planned deviations * Analyze RFT Data and provide trending reports to QA/OPS Supervisors and Managers. Additional Responsibilities: * Must be able to fill in for In-process QA inspectors/auditors when needed.
    $97k-120k yearly est. 60d+ ago
  • SR Automation Engineer

    Pharmatek Consulting 4.0company rating

    Indianapolis, IN Jobs

    span id="spandesc"p style="margin:0px; padding:0px; color:rgb(49, 57, 73); font-family:PuviMedium; font-size:14px; font-style:normal; font-weight:400; letter-spacing:normal; orphans:2; text-indent:0px; text-transform:none; widows:2; word-spacing:0px; white-space:normal; background-color:rgb(255, 255, 255)"span style="outline:0px; font-size:12pt; font-family:Aptos, sans-serif"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"SR Automation Engineer/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin:0px; padding:0px; color:rgb(49, 57, 73); font-family:PuviMedium; font-size:14px; font-style:normal; font-weight:400; letter-spacing:normal; orphans:2; text-indent:0px; text-transform:none; widows:2; word-spacing:0px; white-space:normal; background-color:rgb(255, 255, 255)"span style="outline:0px; font-size:12pt; font-family:Aptos, sans-serif"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"Fulltime role at Indianapolis, IN/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin:0px; padding:0px; color:rgb(49, 57, 73); font-family:PuviMedium; font-size:14px; font-style:normal; font-weight:400; letter-spacing:normal; orphans:2; text-indent:0px; text-transform:none; widows:2; word-spacing:0px; white-space:normal; background-color:rgb(255, 255, 255)"span style="outline:0px; font-size:12pt; font-family:Aptos, sans-serif"span style="outline:0px; color:rgb(49, 57, 73); font-family:PuviMedium; font-size:14.6667px; font-style:normal; font-weight:400; letter-spacing:normal; orphans:2; text-indent:0px; text-transform:none; widows:2; word-spacing:0px; white-space:normal; background-color:rgb(255, 255, 255); float:none; display:inline !important"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"Annual base pay of $126k/yr plus benefit/span/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Primarily supporting CTH (Cartridge Tray Handling) and STH (Syringe Tray Handling) platforms/spanspan class="size" style="font-size:14.6667px"br//span/span/ppspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'bspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"Project Delivery Support -/span/span/b/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Provide automation/mechanical technical support for troubleshooting during the commissioning and qualification phase./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Perform amp;/or support the execution of commissioning and qualification testing on the equipment./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Provide technical support for integration of the line with site automation systems and other ancillary equipment (ie: MES)/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Perform source code review and code management for associated manufacturing equipment/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Update technical design documentation with respect to project delivery change management processes./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Support site engineering initiatives including but not limited to training/development of site staff, drafting technical procedures, troubleshooting guides/span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pdivspan style='font-size:12pt; font-family:"Aptos", sans-serif'bspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Knowledge sharing -/span/span/b/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/divp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Serve as a key resource to support site engineering groups./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Communicate continuous improvement solutions to respective GR platform stewards, and gain support for ideas on issue resolution./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span style='font-size:12pt; font-family:"Aptos", sans-serif'span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Hands-on resource to help troubleshoot issues but also be primary point of contact for GR personnel when trying to resolve items./span/span/spanspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pdivbr//div/spanbr/span id="spanreq"h3Requirements/h3p style="margin-top:0px"bspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"Basic Requirements/span/span/bspan class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Bachelor's degree in an Engineering discipline or equivalent experience in pharmaceutical parenteral manufacturing./spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Experience working with and programming automated equipment including vision systems, high-speed mechanical assembly lines, Fanuc robotics./spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Minimum of three (3) years' experience with pharmaceutical manufacturing, additional benefit if direct experience with:/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o high-speed device assembly,/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o packaging manufacturing equipment,/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o parenteral manufacturing equipment (filling/inspection lines)/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Automated Storage Retrieval Systems (ASRS)/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"o Automated Guided Vehicles (AGV)/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Knowledge on Documentation management, and ability to execute Test Cases, Checklists and capture a pending point list with appropriate responsible and resolution/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Ability to program Rockwell PLC, FactoryTalk HMI/SCADA systems with hands-on troubleshooting experience./spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Experience working hands-on with mechanical assembly machines, pneumatics, instrumentation, electrical drawings, etc./spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Experience working with vendors/OEM personnel/spanspan class="size" style="font-size:14.6667px"br//span/span/pp style="margin-top:0px"span class="font" style="font-family:verdana, sans-serif"span class="size" style="font-size:14.6667px"• Strong communicator, as individual will be attending many remote meetings with Global Robotics personnel via Teams. Strong ability to escalate and work cross-functionally./spanspan class="size" style="font-size:14.6667px"br//span/span/pdivbr//div/spanbr/
    $126k yearly 60d+ ago
  • Senior Automation Engineer

    Pharmatek Consulting 4.0company rating

    Charlotte, NC Jobs

    Fulltime opportunity Concord in Charlotte, NC Annual base pay of $126k/yr plus benefit • Primarily supporting STH (Syringe Tub Handling) platforms • Secondary support for LLRS (literature loading) and BACS (Bin assembly and Collapsing system) platforms Project Delivery Support - o Provide automation/mechanical technical support for troubleshooting during the commissioning and qualification phase. o Perform &/or support the execution of commissioning and qualification testing on the equipment. o Provide technical support for integration of the line with site automation systems and other ancillary equipment (ie: MES) o Perform source code review and code management for associated manufacturing equipment o Update technical design documentation with respect to project delivery change management processes. o Support site engineering initiatives including but not limited to training/development of site staff, drafting technical procedures, troubleshooting guides • Knowledge sharing - o Serve as a key resource to support site engineering groups. o Communicate continuous improvement solutions to respective GR platform stewards, and gain support for ideas on issue resolution. o Hands-on resource to help troubleshoot issues but also be primary point of contact for GR personnel when trying to resolve items. Requirements Basic Requirements • Bachelor's degree in an Engineering discipline or equivalent experience in pharmaceutical parenteral manufacturing. • Experience working with and programming automated equipment including vision systems, high-speed mechanical assembly lines, Fanuc robotics. • Minimum of three (3) years' experience with pharmaceutical manufacturing, additional benefit if direct experience with: o high-speed device assembly, o packaging manufacturing equipment, o parenteral manufacturing equipment (filling/inspection lines) o Automated Storage Retrieval Systems (ASRS) o Automated Guided Vehicles (AGV) • Knowledge on Documentation management, and ability to execute Test Cases, Checklists and capture a pending point list with appropriate responsible and resolution • Ability to program Rockwell PLC, FactoryTalk HMI/SCADA systems with hands-on troubleshooting experience. • Experience working hands-on with mechanical assembly machines, pneumatics, instrumentation, electrical drawings, etc. • Experience working with vendors/OEM personnel • Strong communicator, as individual will be attending many remote meetings with Global Robotics personnel via Teams. Strong ability to escalate and work cross-functionally.
    $126k yearly 60d+ ago
  • Software Quality Engineer

    BVI 3.5company rating

    Irvine, CA Jobs

    Job Requisition Name Software Quality Engineer Job Requisition No VN8196 USA - Irvine Worker Basis Full Time Worker Type Employee Applications Close Date Sep 30, 2025 Purpose As a Software Quality Engineer, you will be responsible for ensuring compliance with design control, risk management, usability, and software validation requirements throughout the development lifecycle of advanced ophthalmic surgical systems. You will support Design Control processes by working closely with cross-functional teams to help develop safe, effective, and regulatory-compliant software-driven medical equipment. You will provide technical guidance on software-related quality assurance, including compliance with IEC 62304 and related standards. This is a global role, with a strong focus on overseeing third-party partners involved in the design, development, and manufacturing of active surgical equipment for ophthalmic use. * Serve as the Quality core team member on new product development and sustaining initiatives for surgical capital equipment * Develop, implement, and maintain QMS elements to ensure product quality throughout the lifecycle, including coordination with third-party QMS when needed * Provide guidance on system and software design controls, validation, and verification processes * Ensure compliance with IEC 60601 for electrical safety, electromagnetic compatibility (EMC), and essential performance * Lead risk management activities for software in line with ISO 14971 and IEC 62304, including classification and mitigation strategies * Guide usability engineering per EN 62366, including human factors validation and interface risk management * Review and approve software documentation, including requirements, architecture, risk management files, and V&V plans * Support cybersecurity risk management and ensure alignment with relevant standards * Oversee design transfer activities to ensure software quality is preserved during manufacturing handoff * Provide quality input into complaint analysis, nonconformances, and health hazard assessments * Lead or support CAPA activities and use systematic problem-solving methods to resolve quality issues * Lead internal/external audits and supplier evaluations; report on quality metrics and compliance gaps * Collaborate with senior management and regulatory authorities as needed * Bachelor's degree in Software Engineering, Biomedical Engineering, Life Sciences, or a related field * Minimum 5 years of experience in software quality engineering within the medical device industry * Experience with active medical devices and embedded software development is preferred * Strong understanding of software design controls and relevant standards (IEC 62304, ISO 14971, IEC 60601) * Familiarity with FDA, EU MDR, ISO 13485, and other applicable regulations * Proficiency in software validation, risk management, and cybersecurity practices * Strong analytical and problem-solving abilities * Experience using statistical tools such as Minitab is a plus * Excellent communication and collaboration skills * Ability to work cross-functionally with R&D, Manufacturing, and Regulatory Affairs * Willingness to travel occasionally for audits or supplier visits BVI is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at ******************
    $99k-142k yearly est. 60d+ ago
  • Sr. Automation Engineer

    Pacira Pharmaceuticals 4.7company rating

    San Diego, CA Jobs

    About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together. Summary: This position assumes responsibility as the technical owner of various commercial manufacturing and supporting control systems and applies available resources to manage them. This position will maintain existing control systems and plan and execute automation/controls projects from concept to final closeout in support of site objectives. Responsibilities Essential Duties & Responsibilities: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. 1. Work with the facilities department to troubleshoot BMS and other control system related issues. 2. Troubleshoot and diagnose complex control system problems, working closely with Metrology, Facilities, MS&T, and other teams. 3. Ensure business continuity thru appropriate maintenance of control systems and software as the automation technical lead supporting commercial manufacturing. 4. Provide on-call support for commercial manufacturing on a rotating basis with other team members. 5. Engineer and manage medium to large process control system/equipment improvements, expansions, and upgrade projects to meet site objectives. 6. Provide moderate to advanced technical assistance to site operating groups through investigations, control system risk assessments, and design support. 7. Apply cGMP principles within the workplace. Incorporate cGMP and regulatory compliance into all assigned project scopes, design, and construction activities. 8. Work closely with IT infrastructure and support groups as a cross-functional team member to meet automation project objectives. 9. Assist in preparation and execution of the validation qualification protocols related to automation software and control systems. 10. Provide technical and non-technical feedback to validation personnel for the successful qualification of systems. 11. Update, develop, and maintain user requirement specifications, functional specifications, design specifications, and operation and maintenance procedures for new and existing control systems. 12. Contribute to quality event (QE) investigations and corrections. Supervisory Responsibilities: This position has no direct reports. Interaction: The incumbent works closely with all functional areas and directly with the commercial team. Qualifications Education and Experience: * Bachelor's degree in Electrical/Controls or Mechanical Engineering (BSEE or BSME) or other relevant field required * 8 years of relevant experience required * 5 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment preferred * Siemens Apogee BMS or AVEVA System Platform experience preferred. Hands on experience with Windows Servers hardware and Microsoft Windows - applications. * Extensive cross-functional team experience, including technical and non-technical work * Recognized as a technical expert by peers and other personnel within the business unit * Successful track record of managing wide-ranging activities within the business unit * Demonstrates independent project management skills to successfully deliver automation projects to completion. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge, Skills, and Abilities: * To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Knowledge, Skills, and Abilities: * Hands-on experience with Siemens control panels, PPCL programming, Siemens Desigo, Allen-Bradley PLCs, VFDs, Rockwell HMI and programming software, AVEVA (Wonderware) System Platform, and various types of server-based software. * Possesses a high level of technical expertise of process control systems, facility equipment and systems that support manufacturing production, process instrumentation, PID control loops, and related electrical and electronic equipment. * This position requires a high degree of analytical skills and knowledge of automation engineering solutions to improve processes and integrate new equipment to meet company and project objectives. * Ability to perform automation engineering tasks and implementations under limited supervision. * Ability to organize and present technical topics and project overviews. * Maintains up-to-date technical knowledge and skillsets. Shows initiative by developing new methodologies or technologies for process control systems. * The position will require up to 15% travel for equipment and software FATs, system evaluations, conferences, and technical training. Physical Demands: While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds. Work Environment: * Typical office setting with a laboratory, offices, and cubicles * Manufacturing clean rooms and gowning * Equipment/utility areas Benefits * Medical, Prescription, Dental, Vision Coverage * Flexible Spending Account & Health Savings Account with Company match * Employee Assistance Program * Mental Health Resources * Disability Coverage * Life insurance * Critical Illness and Accident Insurance * Legal and Identity Theft Protection * Pet Insurance * Fertility and Maternity Assistance * 401(k) with company match * Flexible Time Off (FTO) and 11 paid holidays * Paid Parental Leave Pay Transparency The base pay range for this role in California is $120,000 annually to $165,000 annually The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. EEO Statement EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose. Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
    $120k-165k yearly 60d+ ago
  • Automation Engineer

    Azzur Group 3.7company rating

    Boston, MA Jobs

    Job Description Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking candidates who are passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun! Azzur Group is seeking an experienced Automation Engineer to join our team in the Boston area. The ideal candidate will be responsible for the Commissioning, Qualification, and Validation (CQV) of automated systems in pharmaceutical manufacturing. In this role you must be able to identify critical interfaces between building and equipment systems; interpret P&IDs, wiring diagrams, facility/equipment drawings, and equipment specifications to determine automation strategies for the GMP manufacturing facility; and effectively perform troubleshooting and repair activities. Key Responsibilities: Lead design, configuration, and commissioning of DeltaV and PAS-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls, deviations, and CAPAs involving DeltaV and PAS-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. Provide hands-on troubleshooting and root cause analysis for DeltaV and PAS-X system issues during routine operations and project start-up phases. Collaborate with cross-functional teams (Process Engineering, QA, Validation, and Manufacturing) to align automation changes with business needs. Author and review technical documentation including Functional Design Specs (FDS), software requirement specs, and test protocols. Interface with PAS-X MES and data historians to ensure integration and data continuity across digital systems. Participate in system upgrades, patching, and security hardening activities to maintain compliance and cyber-resilience of DeltaV and PAS-X environments. Train and mentor site engineers/operators on DeltaV and PAS-X operations, change management, and system maintenance best practices. Ensure automation compliance with GAMP 5, FDA 21 CFR Part 11, and relevant corporate SOPs and regulatory requirements. Requirements Bachelor’s degree in Chemical, Electrical, Mechanical, Biomedical Engineering, or Computer Science with appropriate industrial controls experience. 4+ years of experience in manufacturing support environment, as a system integrator or automation engineer. PLC and DCS coding, installation, and support, including but not limited to Allen Bradley, Siemens, and DeltaV. Understanding and configuration of systems such as PI, Win-911, and InfoBatch. Experience with analytical equipment such as balances, pH/DO meters, Nova FLEX2, Beckman Coulter Vi-CELL, filter integrity testers, etc. Understanding of instrumentation, electrical, and wiring standards. Understanding of network architecture, including firewall and switch configuration and virtualized environments. Familiarity with industry standard communication protocols such as Ethernet IP, PROFINET, Modbus TCP, OPC, and BACnet. Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures. In-depth knowledge of pharmaceutical manufacturing practices, particularly GMP compliance. Excellent communication skills, with the ability to collaborate across teams and document technical information clearly. Strong problem-solving abilities and attention to detail. Benefits Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays)
    $79k-106k yearly est. 22d ago
  • Automation Engineer

    Azzur 3.7company rating

    Boston, MA Jobs

    Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking candidates who are passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun! Azzur Group is seeking an experienced Automation Engineer to join our team in the Boston area. The ideal candidate will be responsible for the Commissioning, Qualification, and Validation (CQV) of automated systems in pharmaceutical manufacturing. In this role you must be able to identify critical interfaces between building and equipment systems; interpret P&IDs, wiring diagrams, facility/equipment drawings, and equipment specifications to determine automation strategies for the GMP manufacturing facility; and effectively perform troubleshooting and repair activities. Key Responsibilities: * Lead design, configuration, and commissioning of DeltaV and PAS-X automation systems for GMP-critical manufacturing equipment and process controls. * Support change controls, deviations, and CAPAs involving DeltaV and PAS-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. * Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. * Provide hands-on troubleshooting and root cause analysis for DeltaV and PAS-X system issues during routine operations and project start-up phases. * Collaborate with cross-functional teams (Process Engineering, QA, Validation, and Manufacturing) to align automation changes with business needs. * Author and review technical documentation including Functional Design Specs (FDS), software requirement specs, and test protocols. * Interface with PAS-X MES and data historians to ensure integration and data continuity across digital systems. * Participate in system upgrades, patching, and security hardening activities to maintain compliance and cyber-resilience of DeltaV and PAS-X environments. * Train and mentor site engineers/operators on DeltaV and PAS-X operations, change management, and system maintenance best practices. * Ensure automation compliance with GAMP 5, FDA 21 CFR Part 11, and relevant corporate SOPs and regulatory requirements.
    $79k-106k yearly est. 21d ago

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