Validation Engineer (Contractor)

Motion Recruitment; Oceanside (CA); On-site; USD 96,000 - 152,000; Full time

Job summary

Motion Recruitment seeks an experienced Validation Engineer contractor in Oceanside, CA to author, execute, and summarize qualification activities for GMP manufacturing equipment, CIP/SIP systems, and single-use facilities.

Requires 8–10+ years in cGMP validation, strong technical writing, and the ability to manage timelines independently.

Qualifications

• 8–10+ years of direct validation engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Hands-on experience authoring and executing Equipment Validation (IQ/OQ/PQ) and Cleaning Validation (CV, CV sampling plans, residue limits, recovery studies).
• Excellent technical writing and cross-functional collaboration skills; able to manage timelines independently.

Responsibilities

• Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
• Develop and execute Cleaning Validation and verification protocols, including sampling plans and data coordination (TOC, conductivity, bioburden, endotoxin).
• Evaluate validation results against acceptance criteria and document protocol exceptions with stakeholders.
• Document validation activities and maintain records; support process improvements.

Skills

Technical writing

Cross-functional collaboration

Communication

Timeline management

Education

BS or MS in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or related field

Job description

Job Title: Validation Engineer

Job Location: Oceanside, CA 92056

Job Duration: 24Months with Possible Extn - Onsite

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.