- Frederick, Maryland, United States
- 5+ years
Lead and execute full lifecycle validation projects for biotech, pharma, and life science clients, ensuring compliance with regulatory standards.
Responsibilities
- Lead and execute full lifecycle validation projects, from planning through final summary report
- Write, review and execute validation deliverables, including validation plans, URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices and summary reports
- Qualify laboratory equipment, manufacturing equipment, utilities, facilities and computerized systems
- Support commissioning, FAT/SAT and the handoff into qualification
- Investigate and document deviations, discrepancies and change controls during execution
Requirements
- Bachelor's degree in engineering, life sciences or a related field, or equivalent experience
- Nice to have: Computer system validation (CSV)
- Nice to have: CSA experience
- Nice to have: cleaning, process or cleanroom validation experience
- Nice to have: electronic validation or quality systems