Process Validation Engineer

Job Description

Job Description

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.