Senior Computer Systems Validation Engineer (FDA-regulated)

Barry-Wehmiller Companies Inc.; Carmel (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GAMP5 knowledge

21 CFR Part 11 knowledge

Software validation writing

Education

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

Job description

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.