The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and systems remain compliant with cGMP regulations
Job Summary
The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and systems remain compliant with cGMP regulations.
This role involves leading validation activities, authoring protocols, and managing external vendors for capital projects and ongoing operations.
Candidates must demonstrate expertise in areas such as cleaning validation, aseptic process simulation, and computer system validation within a regulated environment.
Matching Summary
The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and systems remain compliant with cGMP regulations.
Skills & Requirements
Must-have
Bachelor's degree in Engineering or Life Sciences
5+ years professional validation experience
4+ years cGMP pharmaceutical environment
Subject Matter Expertise in validation disciplines
Experience with GMP utilities like WFI and HVAC
Nice-to-have
Master's degree preferred
Experience supporting FDA/EMA inspections
Capital project design and commissioning experience