Senior Validation Engineer, GMP Equipment & Utilities

Jobot; Costa Mesa (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Jobot is seeking a Senior Validation Engineer to design, execute, and maintain validation programs within a GMP‑regulated manufacturing environment in California. You will validate equipment, utilities, laboratory systems and computerized systems while ensuring quality and regulatory requirements are met.

This hands-on role requires direct experience performing validation activities, not only reviewing documentation, and offers the opportunity to work with experienced teams to keep manufacturing

Qualifications

• Bachelor’s degree in engineering, life sciences or a related field.
• Hands-on validation experience within a GMP-regulated pharmaceutical environment.
• Experience developing and executing IQ/OQ/PQ protocols.
• Strong documentation and technical writing skills.

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 steam and dry-heat sterilizers using Kaye validation systems.
• Develop new sterilization cycles when needed.
• Validate autoclaves, lyophilizers and other manufacturing equipment.
• Review manufacturing and laboratory equipment periodically.
• Maintain calibration records and calibrate equipment as needed.
• Implement Validation Master Plans for equipment and processes.
• Validate utilities such as water systems and air-handling units.
• Support 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.
• Issue maintenance work orders and recommend equipment or process improvements.

Skills

Hands-on validation

GMP compliance

Technical writing

Documentation

Education

Bachelor’s degree in engineering or life sciences

Tools

Kaye validation systems

Microsoft Word

Excel

PowerPoint

Job description

Jobot is seeking a Senior Validation Engineer to design, execute, and maintain validation programs within a GMP‑regulated manufacturing environment in California. You will validate equipment, utilities, laboratory systems and computerized systems while ensuring quality and regulatory requirements are met.

This hands-on role requires direct experience performing validation activities, not only reviewing documentation, and offers the opportunity to work with experienced teams to keep manufacturing