Validation Engineer

Motion Recruitment; Oceanside (CA); On-site; USD 110,000 - 165,000; Full time

Job summary

Motion Recruitment is seeking an experienced Validation Engineer (Contractor) toSupport the Validation Engineering team in authoring, executing, and summarizing equipment qualification and cleaning validation activities for GMP biopharma facilities. The role requires hands-on experience with CIP/SIP systems and strong communication skills.

The ideal candidate brings 8–10+ years in validation, with direct experience in equipment validation (IQ/OQ/PQ) and cleaning validation, plus the ability to

Qualifications

• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotechnology facility.
• Hands-on experience authoring and executing Equipment Validation (IQ/OQ/PQ) and Cleaning Validation (CV/CV testing).
• Experience coordinating analytical data (TOC, conductivity, bioburden, endotoxin).
• Excellent technical writing and cross-functional communication skills.

Responsibilities

• Protocol authoring, review, and execution for IQ, OQ, PQ.
• Develop and execute Cleaning Validation protocols and sampling plans.
• Coordinate analytical testing and data review to meet acceptance criteria.
• Document validation activities and maintain records.
• Support continuous process and validation improvements.

Skills

Technical writing

Communication

Independent time management

Education

B.S./M.S. in Chemical Eng. or related

Job description

Contract: 12 months+ (Will be ext possibility)

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.