Minimum 5 years professional validation experience
4+ years direct cgmp pharmaceutical environment experience
The Validation Engineer III serves as a Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with cGMP requirements
Job Summary
The Validation Engineer III serves as a Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with cGMP requirements.
This role involves leading validation activities, authoring protocols, and managing external vendors to support ongoing operations and capital projects.
Barry-Wehmiller is a diversified global supplier committed to using the power of business to build a better world through people-centric leadership.
Matching Summary
The Validation Engineer III serves as a Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with cGMP requirements.
Skills & Requirements
Must-have
Bachelor's degree in Engineering or Life Sciences
Minimum 5 years professional validation experience
4+ years direct cGMP pharmaceutical environment experience
Expertise in IQ/OQ/PQ protocol execution
Knowledge of ALCOA+ data integrity principles
Experience with GMP utilities like WFI and HVAC
Nice-to-have
Master's degree in related scientific discipline
Experience supporting FDA or EMA regulatory inspections
Capital project experience in equipment design
Proficiency with electronic validation systems
Self-motivated problem-solving abilities
Key Requirements
Bachelor's degree required; Master's preferred
Minimum 5 years validation experience
Minimum 4 years cGMP pharmaceutical/biotech experience
SME expertise in specific validation disciplines
Experience with regulatory agency inspections preferred