Process Validation Engineer

Process Validation Engineer Location: Carlsbad, CA Schedule: Hybrid – 3 days onsite / 2 days remote Hours: Monday–Friday, 8:00 AM–5:00 PM 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. Pay: $55.00 - $70.00 per hour Expected hours: 40.0 per week Application Question(s): * Do you have 7+ years of experience in a cGMP environment, including 5+ years in Process Validation, PPQ and/or CPV, hands-on BLA filing/FDA regulatory experience, and commercial manufacturing experience, along with a Bachelor’s or Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or a related Life Science field? Education: * Bachelor's (Preferred) Experience: * GMP: 7 years (Preferred) * process validation, PPQ, and/or CPV: 5 years (Preferred) * BLA filing and FDA/regulatory: 3 years (Preferred) * Commercial manufacturing: 2 years (Preferred) Work Location: In person