Process Validation Specialist - Torrance

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

Process Validation Specialist

Location: Torrance, CA | Employment Type: Full-Time

Support compliant, reliable manufacturing for clinical and commercial products.

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.

About The Role

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.

What You Will Do

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

What We Are Looking For

Education and Experience

• 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.

Technical Skills

• 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.

Skills And Competencies

• 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.

Why Join PolyPeptide?

At PolyPeptide, your work supports the manufacturing of peptide based therapies that can make a meaningful impact for patients. In this role, you will help strengthen validation practices, support process reliability, and contribute to successful manufacturing outcomes for clinical and commercial programs.

If you are looking to grow your validation experience in a technical, quality focused, and collaborative environment, we encourage you to apply.

Work Environment

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.

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.