Computer System Validation Engineer
Core
Support capital projects and deliver computer systems validation solutions for FDA-regulated clients in production, process control, and stand-alone systems.
Role type
Computer Systems Validation Engineer
Builds
Validation documentation, test scripts (SFATs, HFATs, IQs, OQs), and traceability matrices for compliant systems.
Domain
Life sciences, pharmaceuticals, biotech, medical devices, FDA-regulated industries
Required skills
Computer systems validation, cGMP, FDA CQV methods, GAMP5, 21 CFR Part 11, ALCOA+ principles, technical writing, project management
Preferred skills
FDA Data Integrity, Emerson DeltaV, Allen Bradley PLC, Wonderware, OSI PI, Rockwell software, laboratory systems, bioprocess manufacturing equipment
Responsibilities
Prepare and execute computer systems validation documents, develop and execute validation test scripts, review engineering documents, support capital projects, collaborate with clients and project teams
Seniority
Mid-level, hands-on IC