Senior Validation Engineer - CQV (Biotech/cGMP)

Dawar Consulting

Oceanside (CA)

On-site

USD 97,000 - 138,000

Full time

4 days ago
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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

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.

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