Process Validation Engineer

Location: Carlsbad, CA

Schedule: Hybrid – 3 days onsite / 2 days remote

Hours: Monday–Friday, 8:00 AM–5:00 PM

Duration: 12 months with possible extension

Pay Rate: $57–$72/hr W2

Type: Temp-to-Hire Potential

Role Overview: Seeking a Process Validation Engineer to lead and manage process validation activities within a GMP viral vector manufacturing facility. This role will work closely with Manufacturing, Process Development, QA, QC, and Project Management teams to ensure compliant and scientifically sound validation strategies.

Key Responsibilities: Develop and manage process validation, PPQ, and CPV activities. Develop, review, and approve validation protocols, reports, risk assessments, and impact assessments. Lead validation studies, investigations, process capability assessments, and continuous improvement activities. Define validation strategies for manufacturing processes, equipment, facilities, utilities, and cleaning. Analyze process/product data and support process control strategies. Serve as a Process Validation SME during audits and customer meetings. Collaborate with cross-functional teams and external manufacturers/suppliers. Support regulatory and customer requirements, including BLA/FDA filing activities.

Required Qualifications: 7+ years of experience in a cGMP environment.5+ years of process validation, PPQ, and/or CPV experience. Experience with BLA filing and FDA/regulatory agency requirements. Commercial manufacturing experience. Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or related Life Science field. Strong technical writing, documentation, data analysis, and project management skills.

Preferred Qualifications: 10+ years of manufacturing/process validation experience. Experience with cell culture upstream or downstream purification operations. Experience with TFF, UF/DF, chromatography (AKTA/XMO), bioreactors, clarification, or sterile filtration. Process development and/or manufacturing expertise. Chemistry background. Strong ability to lead cross-functional teams and work independently.