Process Validation Specialist - Torrance

At PolyPeptide, we partner with pharmaceutical and biotech companies to support the development and manufacturing of peptide based therapies. We are looking for a Process Validation Specialist to help ensure our manufacturing processes are compliant, reproducible, and ready to support high quality clinical and commercial production.

This role is a great fit for someone who enjoys technical documentation, data review, validation execution, and working with cross functional teams in a fast paced cGMP environment.

The Process Validation Specialist supports process validation activities through protocol preparation, execution support, data review, and documentation. This role works closely with Manufacturing, Quality, Engineering, and R&D to support process validation, equipment qualification, cleaning validation, and continued process verification activities.

You will play an important role in helping ensure manufacturing processes meet regulatory expectations, internal quality standards, and customer delivery commitments.

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  Execute and maintain process validation protocols, reports, and documentation, including IQ, OQ, and PQ activities.

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  Support cleaning validation, equipment qualification, and continued process verification programs.

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  Assist with planning and coordinating validation activities for new processes, technology transfers, and scale ups.

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  Review and analyze process data to help identify critical process parameters and support process robustness.

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  Collaborate with Manufacturing, Quality, Engineering, and R&D to define validation requirements and resolve deviations.

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  Participate in root cause investigations and support CAPA implementation related to process deviations.

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  Support internal audits, external audits, and regulatory inspections by providing validation documentation and subject matter support.

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  Assist with validation lifecycle activities, including periodic requalification and risk assessments.

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  Maintain compliance with cGMP requirements, FDA, EMA, ICH Q8 through Q10, and applicable industry best practices.

• 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.

• Working knowledge of cGMP regulations, ICH guidelines, and validation lifecycle principles.

• Experience with protocol generation, execution, documentation, and deviation or CAPA support.

• Familiarity with process development, manufacturing operations, and data analysis.

• Experience with statistical analysis tools such as Minitab is a plus.

• Strong technical writing, analytical, and organizational skills.

• High attention to detail and a quality focused mindset.

• Ability to manage multiple priorities and meet deadlines.

• Effective communication and collaboration across technical, quality, and manufacturing teams.

• Strong problem solving skills and ability to support risk based validation decisions.

• Commitment to compliance, inspection readiness, and continuous improvement.

This role may involve work in an office, laboratory, or GMP manufacturing environment. Depending on project needs, work may require gowning and PPE in controlled areas.

Physical requirements may include prolonged sitting or standing, movement between work areas, occasional lifting of up to 25 pounds, repetitive tasks, and potential exposure to chemicals, equipment noise, or temperature controlled environments. Occasional evening, weekend, or overtime hours may be required to support production or testing deadlines.

Reasonable accommodations will be made as needed.

Join PolyPeptide and help support compliant, high quality manufacturing for the future of peptide based therapies.

Salary: $80k-$100k

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.