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. xhqgsiq
- Strong ability to lead cross-functional teams and work independently.
Process Validation Engineer in carlsbad at Unknown Company
This position is listed as full time and able to be worked remotely.