Biopharma Validation Engineer: CQV, GMP Compliance & Growth

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

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.