Senior Validation Engineer – GMP Sterile Systems

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. 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 just documentation review. The position reports to Validation Leadership and offers the opportunity to work closely with

Qualifications

• Bachelor’s degree in engineering, life sciences or a related field.
• Hands‑on validation experience within a GMP‑regulated pharmaceutical, biotechnology or similar manufacturing environment.
• Experience developing and executing IQ/OQ/PQ protocols.
• Strong technical writing and documentation skills.
• Working knowledge of Microsoft Word, Excel and PowerPoint.
• Ability to collaborate effectively with Engineering, Manufacturing and Quality teams.

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

IQ/OQ/PQ protocols

Validation execution

Documentation

Education

Bachelor's degree in engineering, life sciences or related field

Tools

Kaye validation systems

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Jobot is seeking a Senior Validation Engineer to design, execute, and maintain validation programs within a GMP‑regulated manufacturing environment. 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 just documentation review. The position reports to Validation Leadership and offers the opportunity to work closely with