Sr. Validation Engineer - COSTA MESA, CA, US
7 hours ago
Job description
Position Summary
The Senior Validation Engineer is responsible for leading and executing validation activities supporting sterile injectable and biopharmaceutical manufacturing operations. This role ensures that facilities, utilities, equipment, computerized systems, and processes are designed, installed, qualified, and maintained in a validated state in compliance with FDA, EU GMP, ICH, and other global regulatory requirements. The position provides technical leadership, cross-functional collaboration, and subject matter expertise for aseptic processing, cleanroom environments, and contamination control strategies.
Key Responsibilities
Validation & Qualification
- Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines and isolators/RABS, Autoclaves, SIP/CIP systems, Lyophilizers, Sterile filtration systems, cleanrooms and classified areas.
- Author, review, and approve validation protocols, perform and support executions, interpret and review data, and write final reports.
- Develop and maintain Validation Master Plans (VMPs).
- Experience with process and cleaning validations and aseptic process simulations (media fills).
- Lead validation of critical utilities such as Water for Injection (WFI), clean steam, HVAC systems and Compressed gases (CDA, and nitrogen).
- Execute environmental qualification and airflow visualization (smoke studies).
- Validate computerized systems in accordance with GAMP 5 and 21 CFR Part 11.
- Ensure data integrity compliance (ALCOA+ principles).
- Support automation and control systems validation (PLC, SCADA, etc.).
- Ensure validation activities comply with FDA cGMPs (21 CFR Parts 210, 211), and EU GMP Annex 1 (Sterile Manufacturing).
- Support regulatory inspections, customer audits and responses to audits.
Technical Leadership & Continuous Improvement
- Act as Subject Matter Expert (SME) for validation and sterile manufacturing.
- Lead change controls, deviations, CAPAs, and risk assessments (FMEA).
- Drive continuous improvement initiatives to enhance compliance, efficiency, and robustness.
Required Education
- Bachelor's degree in Engineering or related Life Sciences field.
- Excellent technical writing and documentation skills and MS Office (Word, Excel, PowerPoint, etc.).
Experience
- 7+ years of hands-on experience in validation of sterile injectable pharmaceutical or biopharmaceutical industry.
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