Process Validation Engineer
- Location
- Carlsbad, California, United States
- Salary
- Not specified
- Company
- Akash pawar
Job description
• Role & Company / Project Overview BEPC Inc. is seeking an experienced Process Validation Engineer to support a Gene Therapy Viral Vector Manufacturing facility focused on drug substance and drug product manufacturing for gene therapy and oncology applications in Carlsbad, CA. This position is a W2 contract role (12 months with temp-to-hire potential). • Key Responsibilities & Daily Duties - Develop, author, and execute validation strategies, Validation Master Plans, Process Performance Qualification (PPQ) protocols, Continued Process Verification (CPV) plans, and summary reports. - Support Gene Therapy Viral Vector Manufacturing operations for drug substance and drug product manufacturing. - Conduct Critical Quality Attribute (CQA) and Critical Process Parameter (CPP) linkage analysis and lead technical risk assessments. - Support mixing, hold-time, and homogeneity studies across upstream and downstream manufacturing operations. - Interface with regulatory agencies and support BLA filings. • Required Qualifications, Skills & Experience - 7+ years of experience working in a cGMP environment. - 5+ years of dedicated Process Validation, PPQ, and/or CPV experience. - Demonstrated experience with BLA filings and interacting with FDA/regulatory agencies. - Extensive background in commercial manufacturing operations. - Experience developing and executing validation strategies, protocols, and reports. - Strong expertise in biologics process validation, Validation Master Plans, PPQ protocols, CQA/CPP linkage, risk assessments, mixing/hold-time/homogeneity studies, and upstream/downstream manufacturing operations is highly valued. - Education: Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or another Life Science-related field. • Working Hours, Shifts & Location Details - Location: Carlsbad, CA. - Work Model: Hybrid (3 days onsite / 2 days remote). - Contract Type: W2 12-month contract with temp-to-hire potential (W2 only; C2C and C2H are not considered). • Application Instructions - Apply via LinkedIn or submit your resume directly to the designated recruiter.