Technical Source is in search of a Senior Computer Systems Validation Engineer for our pharmaceutical manufacturing client in the Raleigh-Durham-Chapel Hill area. This is a long-term contract position that requires on-site work. Candidates should have experience completing and reviewing CQV documentation for DeltaV.
Job Responsibilities:
- Review and approve Kneat documents such as DeltaV FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Installation Verification protocols.
- Assist in resolving execution issues, providing critical analysis, and developing sound solutions.
- Support development of system requirements and specifications to meet 21 CFR Part 11 standards.
- Ensure high standard Computer System Validation within budget and project timelines, coordinating across workstreams.
Experience & Skills:
- 5+ years of Computer System Validation experience in cGMP pharmaceutical facilities.
- 3+ years working with Emerson DeltaV DCS and related automation control systems.
- Knowledge of Kneat validation software.
- Strong communication skills, team-oriented with organizational and problem-solving abilities.