Senior Validation Engineer - CQV

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

Benefits offered by this job

Medical

Dental

Vision

Paid Sick Leave

401K

Job summary

Dawar Consulting, Inc. supports a world-leading biotechnology client in Oceanside, CA, seeking a Senior Validation Engineer - CQV. The role centers on equipment qualification and cleaning validation for stainless steel and single-use manufacturing processes.

The ideal candidate has 8–10+ years of hands-on validation experience in a cGMP biopharma setting, with IQ/OQ/PQ, CIP/SIP, and cleaning validation expertise. This is a long-term contract position in Oceanside, CA.

Qualifications

• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical manufacturing facility.
• Hands-on authoring and executing IQ/OQ/PQ protocols.
• 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.

Responsibilities

• Author, review, and execute equipment qualification protocols (IQ, OQ, PQ).
• Develop and execute cleaning validation and cleaning verification protocols.
• Perform sampling, visual inspections, and coordinate analytical testing (TOC, conductivity, bioburden, endotoxin).
• Support qualification of biopharmaceutical manufacturing equipment (bioreactors, chromatography skids, TFF systems, autoclaves).
• Evaluate validation results against acceptance criteria and document findings.

Skills

Validation engineering

IQ/OQ/PQ

cGMP knowledge

Analytical testing coordination

Education

Bachelor’s or Master’s degree in Chemical/Biomedical/Mechanical Engineering or related

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