Senior Validation Engineer - GMP Equipment & CV (Onsite)

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

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