Senior Validation Engineer — Grow Impact in GMP Pharma

Jobot

Costa Mesa (CA)

On-site

USD 110,000 - 125,000

Full time

14 days+

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Job summary

Jobot is seeking a Senior Validation Engineer in Costa Mesa, CA, to design, execute, and maintain validation programs in a GMP-regulated manufacturing setting. You will validate equipment, utilities, and laboratory systems while ensuring quality and regulatory compliance.

This is a hands-on role, not limited to reviewing documentation. You will develop IQ/OQ/PQ protocols, write validation reports, and support change controls and quality documentation.

Qualifications

  • Bachelor’s degree in engineering, life sciences or related field required.
  • Hands-on validation experience within GMP-regulated pharmaceutical, biotech, or related manufacturing environment.

Responsibilities

  • Develop and execute IQ, OQ and PQ protocols.
  • Establish validation standards and document test results.
  • Prepare equipment for testing and write final validation reports.
  • Revalidate sterilization processes using validated methods.
  • Validate autoclaves, lyophilizers and other manufacturing equipment.
  • Review manufacturing and laboratory equipment periodically.
  • Maintain calibration records and calibrate equipment as needed.
  • Support validation Master Plans for equipment and processes.
  • Validate utilities such as water systems and air handling units.
  • Assist with change controls, deviations and quality documentation.
  • Create and update standard operating procedures.
  • Conduct risk-based assessments and validate Part 11 systems.
  • Participate in internal and regulatory audits.

Skills

Hands-on validation experience
IQ/OQ/PQ protocols
Technical writing
Cross-functional collaboration

Education

Bachelor’s degree in engineering, life sciences or a related field

Tools

Microsoft Word
Microsoft Excel
Microsoft PowerPoint

Job description

Jobot is seeking a Senior Validation Engineer in Costa Mesa, CA, to design, execute, and maintain validation programs in a GMP-regulated manufacturing setting. You will validate equipment, utilities, and laboratory systems while ensuring quality and regulatory compliance.

This is a hands-on role, not limited to reviewing documentation. You will develop IQ/OQ/PQ protocols, write validation reports, and support change controls and quality documentation.

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