Senior Validation Engineer

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

Senior Validation Engineer

$110000 - $125000 per year | Costa Mesa, CA | On-site | Permanent

A bit about us:

We’re a growing contract development and manufacturing organization that partners with biopharmaceutical companies from early‑stage process development through commercial manufacturing.

Why join us?

This is an opportunity to join a growing organization where your work will have a direct impact on the company’s commercial success. You’ll have the freedom to build relationships, develop new business, and grow strategic accounts without getting lost in a large corporate structure. You’ll also work closely with experienced technical and operational teams while helping biopharmaceutical customers move important therapies from development through commercial manufacturing.

Job Details

Senior Validation Engineer

Industry: Pharmaceutical Manufacturing

Employment Type: Full-Time

Reports To: Validation Leadership

A Bit About Us

Our client is a growing pharmaceutical manufacturing organization operating in a highly regulated environment. They’re looking for an experienced validation professional who enjoys hands‑on work, solving technical problems and ensuring manufacturing systems remain safe, reliable and compliant.

Position Summary

We are seeking a Senior Validation Engineer to design, execute and maintain validation programs within a GMP‑regulated manufacturing environment. This position will validate equipment, utilities, laboratory systems and computerized systems while ensuring all applicable quality and regulatory requirements are met.

This is a hands‑on role requiring direct experience performing validation activities—not solely reviewing documentation.

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.

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.

Preferred Experience

• Autoclave and steam‑sterilization validation.
• Lyophilizer or lyophilization equipment.
• Kaye validation systems.
• Grade A, ISO 5 or Class 100 cleanrooms.
• Aseptic or sterile pharmaceutical manufacturing.
• Equipment calibration and utility‑system validation.
• FDA 21 CFR Part 11 requirements.

Physical and Environmental Requirements

The position may require frequent movement, extended periods of sitting or standing, use of computers and manufacturing equipment, wearing required PPE and occasional exposure to noise, chemicals or varying temperatures. Some bending, reaching, lifting and nonstandard working hours may be required.

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, and local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

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