Computer System Validation Engineer

Barry-Wehmiller • Carmel, IN

3d

About The Position

BW Design Group is hiring a Computer System Validation Engineer to support capital projects and deliver computer systems validation solutions for FDA-regulated clients. The position is part of the Regulatory Compliance Practice and works with clients, project teams, technical specialists, practice leaders, and subject matter experts to prepare, execute, and document validation activities for production, process control, and stand-alone systems. The role helps clients maintain compliant, reliable systems and applies technical expertise across complex life sciences projects.

The engineer prepares and executes validation documents and test scripts, reviews engineering documents, prioritizes and manages validation activities across multiple projects, and communicates technical findings and project needs. The position also applies cGMP, FDA CQV methods, and good documentation practices to support compliant project execution and high-quality client delivery. Travel may be required for project work, installation and start-up activities, meetings, training, and industry events.

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: Senior