Validation Engineer

BioTalent; Tustin (CA); On-site; USD 41,000 - 69,000; Full time

Benefits offered by this job

Competitive pay

Bonuses

401(k) matching

Paid time off

Career growth

Job summary

Avid Bioservices in California seeks a Validation Specialist to support commissioning, qualification and validation activities for GMP equipment, utilities, facilities and computerized systems. You will develop, execute and document IQ/OQ/PQ protocols and final reports, review URS and vendor documents, and perform temperature mapping and requalification of GMP equipment.

This role requires strong attention to detail and cross-functional collaboration.

Qualifications

• Bachelor’s degree in a relevant technical field.
• 2–4 years of experience in validation or a related pharmaceutical/biotechnology industry.
• Familiarity with IQ/OQ/PQ execution and GMP documentation practices.

Responsibilities

• Support CQV activities for GMP equipment, utilities, facilities, and computerized systems.
• Develop, execute, and document validation protocols and final reports (IQ/OQ/PQ).
• Review URS, equipment specs, engineering drawings, P&IDs, calibration records, and vendor docs.
• Perform temperature mapping and requalification of GMP equipment (autoclaves, ovens, refrigerators, freezers, temp-controlled chambers).
• Conduct gap analyses of vendor protocols and evaluate qualification data.
• Coordinate validation activities with QA, Manufacturing, Facilities, Engineering, Supply Chain and external vendors.

Skills

Analytical skills

Organizational skills

Communication skills

Problem-solving skills

Education

Bachelor's degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or a related technical field

Tools

Ellab ValSuite

temperature mapping systems

Job description

Looking to make an impact in the biopharmaceutical industry? Join Avid Bioservices, a leading clinical and commercial biologics CDMO dedicated to developing and manufacturing life‑saving therapies!

What You'll Do:

• Support commissioning, qualification, and validation (CQV) activities for GMP equipment, utilities, facilities, and computerized systems.
• Develop, execute, and document validation protocols and final reports, including IQ/OQ/PQ activities.
• Review User Requirement Specifications (URS), equipment specifications, engineering drawings, P&IDs, calibration records, and vendor documentation.
• Perform temperature mapping and requalification of GMP equipment, including autoclaves, depyrogenation ovens, refrigerators, freezers, and temperature‑controlled chambers.
• Conduct gap analyses of vendor protocols and evaluate qualification data to ensure compliance with approved acceptance criteria.
• Coordinate validation activities with Quality Assurance, Manufacturing, Facilities, Engineering, Supply Chain, and external vendors.
• Maintain accurate validation documentation in accordance with cGMP requirements, FDA regulations, EU GMP guidelines, and GAMP 5 principles.

What We're Looking For:

• Bachelor's degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or a related technical field.
• 2-4 years of experience in validation or a related pharmaceutical/biotechnology industry.
• Familiarity with equipment qualification, utility validation, IQ/OQ/PQ execution, and GMP documentation practices.
• Experience in FDA‑regulated or other regulated manufacturing environments is preferred.
• Experience with temperature mapping systems such as Ellab ValSuite, Lives, or similar tools.
• Strong analytical, organizational, communication, and problem‑solving skills, with excellent attention to detail.

We Offer:

• Competitive hourly compensation
• Performance‑based bonuses
• 401(k) matching
• Paid time off
• Career growth and development opportunities

Work Authorization:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time