Process Validation Specialist - Torrance
About The Position
PolyPeptide partners with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. The Process Validation Specialist will ensure manufacturing processes are compliant, reproducible, and ready to support high-quality clinical and commercial production. This role is ideal for someone who enjoys technical documentation, data review, validation execution, and collaborating with cross-functional teams in a fast-paced cGMP environment. The specialist supports process validation activities through protocol preparation, execution support, data review, and documentation, working closely with Manufacturing, Quality, Engineering, and R&D to support process validation, equipment qualification, cleaning validation, and continued process verification activities. This role is crucial in 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
- Supports the manufacturing of peptide based therapies that can make a meaningful impact for patients.
- Opportunity to strengthen validation practices, support process reliability, and contribute to successful manufacturing outcomes for clinical and commercial programs.
- Grow validation experience in a technical, quality focused, and collaborative environment.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
