Job Title: Process Validation Engineer
Location: Carlsbad, CA (Hybrid)
Pay rate: $57–$72/hr
Duration: 12 months contract (Temp-to-Hire Potential)
Schedule:8:00 AM–5:00 PM | 3 days onsite / 2 days remote
Job Description:
We are seeking an experienced Process Validation Engineer to support validation activities at a GMP gene therapy and viral vector manufacturing facility. The role will provide technical leadership for process validation, PPQ, CPV, risk assessments, investigations, and validation strategy across manufacturing operations.
Key Responsibilities:
- Develop, review, and execute process validation, PPQ, and CPV protocols/reports.
- Lead validation studies, risk assessments, impact assessments, and investigations.
- Develop process control strategies and analyze process/product data.
- Partner with Manufacturing, MSAT, Process Development, QA/QC, and Project Management teams.
- Serve as a Process Validation SME during audits and customer meetings.
- Support continuous improvement and ensure compliance with cGMP and regulatory requirements.
Required Qualifications:
- 7+ years of experience in a cGMP environment.
- Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related Life Sciences.
- 5+ years of process validation, PPQ, and/or CPV experience.
- Experience with FDA/regulatory BLA filings and commercial manufacturing.
- Strong validation project management and technical writing skills.
Preferred:
- 10+ years of manufacturing/process validation experience.
- Experience with cell culture upstream or downstream purification operations.
- Process development/manufacturing expertise and chemistry background.
- Strong cross-functional leadership and problem-solving skills.
