Validation Engineer (Contractor)

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 iscurrently seeking a Validation Engineer for a prominent client of ours. This position is located at Oceanside CA.Details for the position are as follows:

Title: Validation Engineer

Location: Oceanside CA

Duration: 02 Year (With Possible Extension/Hire)

Pay : $75.00 - $80.00/ hours

Job Details

• Author, review, and execute equipment qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and execute Cleaning Validation (CV) and cleaning verification protocols for manufacturing equipment and systems.
• Develop cleaning validation sampling plans, conduct visual inspections, and coordinate analytical testing, including TOC, conductivity, bioburden, and endotoxin.
• Perform equipment qualification and validation activities for bioreactors, chromatography skids, TFF systems, autoclaves, stainless steel equipment, and single-use manufacturing systems.
• Support Clean-in-Place (CIP) and Steam-in-Place (SIP) validation activities.
• Execute cleaning validation studies involving residue limits, swab/rinse sampling, and recovery studies.
• Evaluate validation results against established acceptance criteria, troubleshoot execution discrepancies, and document protocol exceptions.
• Prepare, review, and maintain validation documentation in accordance with applicable regulatory requirements and internal quality standards.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and other cross-functional teams to support validation activities and continuous improvement initiatives.
• Independently manage validation project timelines and ensure timely completion of deliverables.

Required Qualifications

• Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Hands-on experience authoring and executing both equipment qualification (IQ/OQ/PQ) and cleaning validation protocols.
• Strong working knowledge of CIP/SIP systems and cleaning validation methodologies.
• Experience with biopharmaceutical manufacturing equipment, including bioreactors, chromatography skids, TFF systems, autoclaves, stainless steel, and single-use systems.
• Knowledge of cleaning validation testing, including TOC, conductivity, bioburden, endotoxin, residue limits, and recovery studies.
• Strong technical writing, documentation, troubleshooting, and cross-functional communication skills.
• Ability to independently manage multiple validation activities and meet project deadlines.