Senior Computer Systems Validation Engineer (FDA-Regulated)

barrywehmiller; Indianapolis (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

Barry-Wehmiller BW Design Group in Indianapolis is seeking a Computer Systems Validation Engineer to join our Regulatory Compliance Practice. You will collaborate with industry experts to validate distributed control and process control systems, ensuring compliance with cGMP and FDA CQV standards, while delivering high-quality documentation.

You will develop validation scripts, manage cross-functional teams, and communicate findings and project needs to clients, contributing to reliable

Qualifications

• Bachelor's degree in engineering, computer science, or a 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 software development life cycle documentation, including FRSs, SDSs, HDSs, or configuration specifications.
• Ability to travel for project requirements.
• Solid understanding of ALCOA+ principles.

Responsibilities

• 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

Skills

Validation experience

Regulatory compliance

Technical writing

Education

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

Tools

GAMP5

21 CFR Part 11

Job description

Barry-Wehmiller BW Design Group in Indianapolis is seeking a Computer Systems Validation Engineer to join our Regulatory Compliance Practice. You will collaborate with industry experts to validate distributed control and process control systems, ensuring compliance with cGMP and FDA CQV standards, while delivering high-quality documentation.

You will develop validation scripts, manage cross-functional teams, and communicate findings and project needs to clients, contributing to reliable