Process Validation Specialist - Torrance
About The Position
PolyPeptide is seeking a Process Validation Specialist to ensure manufacturing processes are compliant, reproducible, and ready to support high-quality clinical and commercial production. This role involves technical documentation, data review, validation execution, and cross-functional collaboration in a fast-paced cGMP environment. The specialist will support process validation activities, including protocol preparation, execution support, data review, and documentation, working closely with Manufacturing, Quality, Engineering, and R&D. This role is crucial for ensuring manufacturing processes meet regulatory expectations, internal quality standards, and customer delivery commitments.
Requirements
- 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.
- 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.
- 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.
Nice To Haves
- Previous experience in process validation or validation engineering within pharmaceutical, biotech, or CDMO environments is preferred.
- Experience with statistical analysis tools such as Minitab is a plus.
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 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.
- Maintain compliance with cGMP requirements, FDA, EMA, ICH Q8 through Q10, and applicable industry best practices.
Benefits
- Equal opportunity employer status
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
