Validation Engineer (Contractor)

Kelly Services; Oceanside (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Kelly Services seeks an experienced Validation Engineer (Contractor) in Oceanside, CA to lead equipment qualification and cleaning validation activities for GMP manufacturing facilities. The role requires hands-on expertise with CIP/SIP systems, TOC, conductivity, bioburden, and endotoxin analyses, plus strong communication skills and cross-functional collaboration.

The ideal candidate has 8–10+ years in validation engineering at a biopharma/biotech facility, with a BS/MS in a technical field

Qualifications

• 8-10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotech facility.
• Hands-on experience authoring and executing Equipment Validation (IQ/OQ/PQ) and Cleaning Validation (CV).
• Excellent technical writing and cross-functional collaboration skills.
• Proven ability to independently manage timelines.

Responsibilities

• Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
• Develop and execute CV and cleaning verification protocols including sampling plans and test data coordination.
• Ensure compliance with GMP standards and Roche/Genentech quality requirements.
• Document validation activities and maintain records.

Skills

Technical writing

Cross-functional collaboration

Communication

Project management

Education

B.S. or M.S. in Engineering/related discipline

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.

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full‑time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre‑employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP’s Employment Accommodation policy. Applicants need to make their needs known in advance.