Torrance, California, United States · On-site
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Skills: Process Validation, cGMP, IQ/OQ/PQ, Cleaning Validation, Technical Writing
Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · Hybrid
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Torrance, California, United States · On-site
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Executive Home Care, Inc.Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
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Torrance, California, United States · On-site
$32/hr–$38/hr
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Torrance, California, United States • On-site
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The specialist executes and maintains process validation protocols, including IQ, OQ, and PQ activities, to ensure compliant manufacturing. They collaborate with cross-functional teams to support cleaning validation, equipment qualification, and continued process verification.
Requires a Bachelor's or Master's degree in Engineering, Life Sciences, Chemistry, or a related field. Candidates should have 1 to 3 years of experience in cGMP manufacturing, quality, or R&D, preferably within pharmaceutical or biotech environments.
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.
Apply Today
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.
Contract Development & Manufacturing Organization (CDMO) for peptide-based APIs.
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange. Find out more about our current vacancies at: https://polypeptide.teamtailor.com/
Offices: Neuhofstrasse 24, Baar, CH · Limhamnsvägen 108, Malmö, Skåne 20061, SE · 365 Maple Ave, Torrance, CA 90503, US · Chaussee De Tubize 297, Braine-l'Alleud, Nivelles 1420 , BE · K 28 Additional MIDC, Anand Nagar, Ambernath, Thane, Maharashtra 421506, IN
There are currently 503 open healthcare positions in Torrance, CA listed on Clera. New openings are added daily as companies post roles.
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