Unknown Company

Process Validation Engineer (Carlsbad)

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carlsbad, ca • Posted 2 days ago
Remote Full Time nan

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.


Process Validation Engineer (Carlsbad) in carlsbad at Unknown Company

This position is listed as full time and able to be worked remotely.

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