Computer System Validation Engineer

Barry-Wehmiller • Indianapolis, IN

1d

About The Position

The Computer Systems Validation Engineer joins Design Group’s Regulatory Compliance Practice and supports capital projects by delivering computer systems validation solutions for FDA-regulated clients. The role works with clients, project teams, technical specialists, and practice leaders to prepare, execute, and document validation activities for production, process control, and stand-alone systems. The engineer helps clients maintain compliant, reliable systems and applies technical expertise across life sciences projects.

Requirements

• Bachelor's degree in engineering, computer science, or a related technical field.
• At least 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.

Nice To Haves

• 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.

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.
• Create clear validation documentation and support compliant project execution.
• Apply computer systems validation expertise to strengthen client relationships and support high-quality delivery.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level