Validation Engineer II
On-site · Bridgeton, Missouri, United States
Job Summary
Validation Engineer II will execute and support qualification activities for laboratory instruments and computerized systems (IQ, OQ, requalification, and periodic reviews) to ensure GMP-compliant operation and data integrity. The role develops and manages qualification lifecycle documentation (plans, protocols, reports, change controls, deviations), authors User Requirement Specifications (URS), and collaborates with Quality Assurance, Laboratories, Metrology, Engineering, IT, and external vendors to ensure successful qualification execution. Responsibilities include applying risk-based qualification approaches in line with industry guidance, writing periodic reviews, monitoring qualified systems and equipment, maintaining ALCOA/ALCOA+ data integrity, and supporting the development and improvement of qualification strategies, procedures, and best practices.
Required Qualifications
- Bachelor's degree in biology, Chemistry, Engineering, Pharmaceutical Sciences
- 5+ years of laboratory testing experience in a GMP-regulated environment
- 3+ years of experience qualifying laboratory equipment and systems
- Knowledge of analytical instrument qualification (AIQ) practices
- Strong technical writing, communication, and organizational skills
- GMP regulations, internal SOPs, FDA regulations applicable to laboratory operations, 21 CFR Part 11 requirements, Data Integrity principles, change control, and deviation management
- Familiarity with audit trail review processes and electronic data management systems
- Experience authoring URS and qualification documentation for laboratory instruments and computerized systems
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