Process Validation Specialist

About the role

PolyPeptide partners with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. It is looking for a full-time Process Validation Specialist in Torrance, CA, to help ensure manufacturing processes are compliant, reproducible and ready for clinical and commercial production. The role sits in a fast-paced cGMP environment and involves technical documentation, data review, validation execution and cross-functional teamwork.

Key responsibilities

• Prepare, execute and document process validation protocols, including IQ, OQ and PQ activities
• Support cleaning validation, equipment qualification and continued process verification programs
• Help plan and coordinate validation for new processes, technology transfers and scale-ups
• Analyze process data to identify critical process parameters and support process robustness
• Work with Manufacturing, Quality, Engineering and R&D to define validation requirements and resolve deviations
• Take part in root cause investigations and support CAPA implementation
• Support internal, external audits and regulatory inspections with validation documentation
• Assist with periodic requalification and risk assessments, and maintain compliance with cGMP, FDA, EMA and ICH Q8 through Q10

Required profile

• 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 R&D
• Previous process validation or validation engineering experience in pharma, biotech or CDMO settings is preferred
• Ability to handle multiple priorities, communicate across technical, quality and manufacturing teams, and commit to inspection readiness

Required skills

• Working knowledge of cGMP, ICH guidelines and validation lifecycle principles
• Protocol generation, execution, documentation and deviation/CAPA support
• Familiarity with process development, manufacturing operations and data analysis
• Statistical analysis tools such as Minitab are a plus

The work may take place in an office, laboratory or GMP manufacturing environment, with possible gowning and PPE in controlled areas, and occasional evening, weekend or overtime hours. Salary: $80k-$100k.