Senior Biopharma Validation Engineer - IQ/OQ/PQ Expert

Virtual Company; Oceanside (CA); On-site; USD 103,000 - 110,000; Full time

Job summary

The Fountain Group is seeking a Validation Engineer for a prominent client in Oceanside, CA. This role focuses on authoring and executing IQ/OQ/PQ and developing cleaning validation protocols.

You will perform CIP/SIP validation activities, coordinate analytical testing (TOC, conductivity, bioburden, endotoxin), validate bioreactors and single-use systems, and collaborate with Engineering, Manufacturing, and QA to ensure timely project delivery.

Qualifications

• Author, review and execute IQ/OQ/PQ protocols.
• Develop and execute Cleaning Validation (CV) and cleaning verification protocols.
• Create sampling plans and coordinate analytical testing (TOC, conductivity, bioburden, endotoxin).
• Perform equipment qualification and validation on bioreactors, chromatography skids, TFF systems, autoclaves, stainless steel, and single-use systems.
• Support CIP/SIP validation activities.
• Execute cleaning validation studies including residue limits, swab/rinse sampling, and recovery.
• Evaluate validation results against acceptance criteria and document protocol exceptions.
• Prepare and maintain validation documentation per regulatory standards.
• Collaborate with Engineering, Manufacturing, QA, and cross-functional teams.
• Independently manage validation project timelines and deliverables.

Responsibilities

• Author, review, and execute equipment qualification protocols (IQ/OQ/PQ).
• Develop and executeCleaning Validation protocols and sampling plans.
• Coordinate analytical testing (TOC, conductivity, bioburden, endotoxin) for validation activities.
• Validate bioreactors, chromatography skids, TFF systems, autoclaves, stainless steel, and single-use systems.
• Support CIP and SIP validation activities and related studies.
• Document validation results and manage protocol deviations.

Skills

Validation experience

cGMP knowledge

Technical writing

Cross-functional work

Education

Bachelor's or Master's in a related field

Job description

The Fountain Group is seeking a Validation Engineer for a prominent client in Oceanside, CA. This role focuses on authoring and executing IQ/OQ/PQ and developing cleaning validation protocols.

You will perform CIP/SIP validation activities, coordinate analytical testing (TOC, conductivity, bioburden, endotoxin), validate bioreactors and single-use systems, and collaborate with Engineering, Manufacturing, and QA to ensure timely project delivery.