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

Duration: 12 months with possible extension

Pay Rate: $57–$72/hr W2

Type: Temp-to-Hire Potential

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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. xhyhwjd
• Strong ability to lead cross-functional teams and work independently.