Senior Validation Engineer — Grow Impact in GMP Pharma

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

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.