The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with regulatory requirements
Job Summary
The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with regulatory requirements.
This role involves authoring validation protocols, managing external vendors, and leading qualification activities for new capital projects and facility expansions.
Candidates must demonstrate strong technical writing skills and the ability to interface across all organizational levels while maintaining adherence to cGMP standards.
Matching Summary
The Validation Engineer III serves as a key Subject Matter Expert ensuring facility equipment and computerized systems remain compliant with regulatory requirements.
Skills & Requirements
Must-have
Bachelor's degree in Engineering or Life Sciences
5+ years professional validation experience
4+ years cGMP pharmaceutical environment
Expertise in IQ/OQ/PQ protocol execution
Knowledge of ALCOA+ data integrity principles
Nice-to-have
Master's degree preferred
Experience supporting FDA or EMA inspections
Capital project equipment commissioning experience
Proficiency with electronic validation systems
Self-motivated problem-solving abilities
Key Requirements
Bachelor's degree required; Master's preferred
Minimum 5 years validation engineering experience
Minimum 4 years cGMP manufacturing experience
Subject Matter Expertise in specific validation disciplines