| Location | Oceanside, CA |
Focus Areas: Equipment Validation & Cleaning Validation
Position Summary
We are seeking an experienced Validation Engineer (Contractor) to support the Validation Engineering team. In this role, you will be responsible for authoring, executing, and summarizing equipment qualification and cleaning validation activities supporting both commercial stainless steel and single-use manufacturing facilities. The ideal candidate brings hands-on experience with GMP manufacturing equipment, Clean-in-Place (CIP)/Steam-in-Place (SIP) systems, and strong verbal and written communication skills.
Key Responsibilities
Protocol Authoring & Execution
• Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
• Develop and execute Cleaning Validation (CV) and cleaning verification protocols, including sampling plans, visual inspections, and analytical test data coordination (e.g., TOC, conductivity, bioburden, and endotoxin).
• Evaluate validation test results against defined acceptance criteria, resolve execution discrepancies via structured troubleshooting, and author protocol exceptions with cross-functional stakeholders.
• Support continuous improvement in validation processes.
• Document validation activities and maintain records.
Regulatory Compliance & GMP Standards
• Ensure all qualification deliverables are in compliance with industry and regulatory standards, and Roche/Genentech quality standards.
Qualifications
• Education: B.S. or M.S. in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
• Experience:
• 8-10+ years of direct validation engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Direct hands-on experience authoring and executing both Equipment Validation (bioreactors, chromatography skids, TFF systems, autoclaves) and Cleaning Validation (CIP/SIP, residue limits, recovery studies).
• Soft Skills:
• Excellent technical writing, cross-functional collaboration, and communication skills.
• Proven ability to independently manage timelines.