Senior Validation Engineer - CQV

Dawar Consulting; Oceanside (CA); On-site; USD 97,000 - 138,000; Full time

Job summary

Dawar Consulting client in biotechnology seeks a Senior Validation Engineer - CQV in Oceanside, CA. The role centers on equipment qualification and cleaning validation to support commercial biopharmaceutical manufacturing.

Requires 8–10+ years hands-on CQV experience in a cGMP facility, with IQ/OQ/PQ, CIP/SIP, cleaning validation, and testing coordination (TOC, conductivity, bioburden, endotoxin).

Long-term contract with W2 pay, medical/dental/vision benefits.

Qualifications

• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical manufacturing facility.
• Bachelor's or Master's in Chemical/Biomedical Engineering or related field.
• Hands-on IQ/OQ/PQ experience and cleaning validation.
• Familiar with CIP/SIP, residues, and recovery studies.
• Experience with stainless steel and single-use equipment.

Responsibilities

• Author, review, and execute equipment qualification protocols (IQ, OQ, PQ).
• Develop and execute cleaning validation and cleaning verification protocols.
• Coordinate sampling, inspections, and analytical testing (TOC, conductivity, bioburden, endotoxin).
• Support qualification of biopharma manufacturing equipment (bioreactors, chromatography skids, TFF, autoclaves).
• Evaluate validation results against acceptance criteria and maintain documentation.

Skills

Equipment qualification

CIP/SIP systems

Cleaning validation

cGMP knowledge

Sampling coordination

Education

Chemical/Biomedical Eng

Biochemistry

Tools

IQ/OQ/PQ protocols

TOC testing

GMP documentation tools

Job description

Oceanside, United States | Posted on 11/11/2026

Our client, a world leader in biotechnology and life sciences, is seeking a " Senior validation Engineer - CQV" .

Location: Oceanside, CA

Duration: Long-Term Contract (Possibility Of Further Extension)

Pay Rate: $85/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K

Job Summary:

The role will focus on equipment qualification and cleaning validation activities supporting commercial stainless steel and single-use manufacturing operations.

The ideal candidate will have 8–10+ years of hands-on validation engineering experience in a cGMP biopharmaceutical manufacturing environment, with expertise in equipment qualification, CIP/SIP systems, and cleaning validation.

Key Responsibilities

Author, review, and execute equipment qualification protocols, including IQ, OQ, and PQ.

Develop and execute cleaning validation and cleaning verification protocols.

Perform sampling activities, visual inspections, and coordinate analytical testing, including TOC, conductivity, bioburden, and endotoxin.

Support qualification of biopharmaceutical manufacturing equipment, including bioreactors, chromatography skids, TFF systems, and autoclaves.

Evaluate validation results against established acceptance criteria.

Troubleshoot execution discrepancies and prepare protocol exceptions in collaboration with cross-functional teams.

Maintain accurate validation documentation and records in compliance with cGMP and company quality standards.

Support continuous improvement initiatives within validation processes.

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 equipment qualification protocols (IQ/OQ/PQ).

Direct experience with cleaning validation and cleaning verification.

Working knowledge of CIP/SIP systems, residue limits, and recovery studies.

Experience with stainless steel and single-use manufacturing equipment.

Knowledge of GMP requirements and validation documentation practices.

Preferred Technical Experience

Bioreactors and fermentation systems

Chromatography skids

Tangential Flow Filtration (TFF) systems

Autoclaves

TOC and conductivity testing

Bioburden and endotoxin testing

Cleaning validation sampling plans and analytical data review