Computer System Validation Engineer

Caelum Research Corporation; Carmel (IN); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Barry-Wehmiller Design Group is seeking a Computer Systems Validation Engineer to join our US team. You will work with clients and internal teams to ensure FDA-regulated systems meet regulatory requirements and quality standards.

You will contribute to validation activities across production and process control systems, develop test scripts, and document outcomes. A strong background in lifecycle documentation and cGMP practices is essential for success.

Formación

• Bachelor’s degree in engineering, computer science, or related technical field.
• 5+ years of computer systems validation experience in FDA-regulated industries.
• Working knowledge of GAMP5 and 21 CFR Part 11 requirements.
• Experience generating SDLC documentation (FRSs, SDSs, HDSs, or configuration specifications).
• Ability to travel for project requirements.
• Solid understanding of ALCOA+ principles.

Responsabilidades

• Support capital projects and delivering computer systems validation solutions for FDA-regulated clients.
• Collaborate with clients, project teams, and Regulatory Compliance Practice leaders to prepare, execute, and document validation activities for production, process control, and stand-alone systems.
• Validate documents for distributed control, process control, and stand-alone production systems.
• Develop and execute validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs.
• Apply cGMP, FDA CQV methods, and good documentation practices throughout validation deliverables.
• Review engineering documents, set priorities, and manage validation activities across multiple projects.
• Communicate technical findings, deliverable status, and project needs with clients and teams.
• Apply computer systems validation expertise to strengthen client relationships and delivery quality.

Conocimientos

GAMP5 knowledge

21 CFR Part 11 knowledge

Software validation writing

Educación

Bachelor's degree in engineering, computer science, or a related technical field

Descripción del empleo

About Us

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description

Computer Systems Validation Engineer

You will join one of our 45 offices in the US, be part of a committed team of over 1600 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment. When you join Design Group as a Computer Systems Validation Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

• Support capital projects and delivering computer systems validation solutions for FDA-regulated clients.
• Work closely with clients, project teams, technical specialists, and Regulatory Compliance Practice leaders to prepare, execute, and document validation activities for production, process control, and stand‑alone systems.
• This position plays an important role in helping clients maintain compliant, reliable systems, giving you the opportunity to apply technical expertise across complex life sciences projects.
• Prepare and execute computer systems validation documents for distributed control, process control, and stand‑alone production systems
• Develop and execute validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs
• Apply cGMP, FDA CQV methods, and good documentation practices throughout validation deliverables
• Review engineering documents, set priorities, and manage validation activities across multiple projects
• Support capital projects by implementing practical validation solutions aligned with client requirements
• Collaborate with clients and project teams to communicate technical findings, deliverable status, and project needs
• Use technical writing skills to create clear validation documentation and support compliant project execution
• Apply computer systems validation expertise to strengthen client relationships and support high‑quality delivery

What You’ll Bring

• Qualifications: Bachelor's degree in engineering, computer science, or a related technical field
• 5+ years of computer systems validation experience in pharmaceutical, biotech, medical device, or other FDA-regulated industries
• Working knowledge of GAMP5 and 21 CFR Part 11 requirements
• Experience generating software development life cycle documentation, including FRSs, SDSs, HDSs, or configuration specifications
• Ability to travel for project requirements, including installation and start‑up activities, client and company meetings, trainings, seminars, forums, and conventions
• Solid understanding of ALCOA+ principles

Preferred Qualifications

• Competency with FDA Data Integrity requirements and exposure to data integrity risk or gap assessments
• Hands‑on experience with platforms such as Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell software
• Experience with laboratory systems, process control systems, clean utilities, bioprocess manufacturing equipment, or biologic unit operations

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.

Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V

This organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company: Design Group