Process Validation Engineer - cGMP Compliance

PolyPeptide Group; Torrance (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

PolyPeptide Group is seeking a Process Validation Specialist to ensure compliant, reproducible manufacturing for clinical and commercial products. You will execute validation protocols, review data, and collaborate with Manufacturing, Quality, Engineering, and R&D to support validation activities and regulatory readiness.

In this role you will contribute to cleaning validation, equipment qualification, and continued process verification while maintaining cGMP alignment.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 1 to 3 years of experience in cGMP manufacturing, quality, or research and development.
• Previous experience in process validation or validation engineering within pharmaceutical, biotech, or CDMO environments is preferred.

Responsibilities

• Execute and maintain process validation protocols, reports, and documentation, including IQ, OQ, and PQ activities.
• Support cleaning validation, equipment qualification, and continued process verification programs.
• Assist with planning and coordinating validation activities for new processes, technology transfers, and scale ups.
• Review and analyze process data to help identify critical process parameters and support process robustness.
• Collaborate with Manufacturing, Quality, Engineering, and R&D to define validation requirements and resolve deviations.
• Participate in root cause investigations and support CAPA implementation related to process deviations.
• Support internal audits, external audits, and regulatory inspections by providing validation documentation and subject matter support.
• Assist with validation lifecycle activities, including periodic requalification and risk assessments.

Skills

cGMP knowledge

ICH guidelines

Validation lifecycle

Protocol generation

CAPA support

Data analysis

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, Chemistry, or related discipline

Tools

Minitab

Job description

PolyPeptide Group is seeking a Process Validation Specialist to ensure compliant, reproducible manufacturing for clinical and commercial products. You will execute validation protocols, review data, and collaborate with Manufacturing, Quality, Engineering, and R&D to support validation activities and regulatory readiness.

In this role you will contribute to cleaning validation, equipment qualification, and continued process verification while maintaining cGMP alignment.