Process Validation Engineer — cGMP Focus

PolyPeptide Laboratories B.V.; Torrance (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

PolyPeptide Laboratories B.V. in Torrance, CA, is seeking a Process Validation Specialist to support cGMP manufacturing for clinical and commercial products.

The role focuses on validation execution, data review, and cross-functional collaboration to ensure compliant, reproducible processes. Key tasks include IQ/OQ/PQ execution, cleaning validation, equipment qualification, and continued verification, with involvement in risk assessments and CAPA within a fast-paced environment.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 1–3 years of experience in cGMP manufacturing, quality, or R&D.
• Process validation or validation engineering experience in pharma/biotech/CDMO is preferred.

Responsibilities

• Execute and maintain process validation protocols, reports, and documentation (IQ/OQ/PQ).
• Support cleaning validation, equipment qualification, and continued process verification programs.
• Plan, coordinate validation activities for new processes, tech transfers, and scale-ups.
• Review process data to identify critical parameters and support robustness.
• Collaborate with Manufacturing, Quality, Engineering, and R&D to define validation requirements and resolve deviations.
• Participate in root cause investigations and CAPA related to process deviations.
• Support audits and regulatory inspections with validation documentation.
• Assist with validation lifecycle activities including requalification and risk assessments.
• Maintain compliance with cGMP, FDA, EMA, ICH Q8–Q10 and industry best practices.

Education

Engineering/Life Sciences degree

Job description

PolyPeptide Laboratories B.V. in Torrance, CA, is seeking a Process Validation Specialist to support cGMP manufacturing for clinical and commercial products.

The role focuses on validation execution, data review, and cross-functional collaboration to ensure compliant, reproducible processes. Key tasks include IQ/OQ/PQ execution, cleaning validation, equipment qualification, and continued verification, with involvement in risk assessments and CAPA within a fast-paced environment.