Biopharma Process Validation Engineer – PV & Compliance

Genentech; Washington (District of Columbia); On-site; USD 81,000 - 150,000; Full time

Job summary

Genentech Oceanside Operations is seeking a Process Validation Engineer to drive PV strategies, author regulatory documents, and ensure cGMP compliance across MSAT initiatives. You will work with cross‑functional teams to maintain schedules, support product transfers, and improve processes through CAPAs and data‑driven reviews.

The role emphasizes hands‑on PV execution, quality systems, and use of digital tools like Veeva and Smartsheet to streamline documentation and reporting.

Qualifications

• Bachelor’s degree with 4–6 years of relevant industry experience or Master’s with 2–4 years.
• Experience with PV concepts, regulatory submission support, and Quality Systems in cGMP biopharma.
• Strong understanding of biopharmaceutical unit operations and process engineering.
• Excellent attention to detail and data integrity in source data verification.
• Strong communicator and cross‑functional collaborator.

Responsibilities

• Author, edit, and execute PV protocols, reports, and regulatory deliverables per cGMP.
• Perform compliance checks to ensure alignment with raw data.
• Maintain master schedule and track project milestones with PV Lead.
• Assist with product introductions, transfers, and capacity Expansion efforts.
• Facilitate reviews across Quality, MSAT, and Regulatory teams to meet timelines.
• Use Veeva/Smartsheet/AppSheet to track metrics and docs workflows.
• Support root‑cause investigations and CAPA implementation.
• Collaborate with senior engineers on equipment qualifications and cleaning validation.

Skills

Process validation

Technical writing

Regulatory submissions

Quality systems

cGMP biopharma

Education

Bachelor's in Chemical Engineering

Master's in Chemical Engineering

Tools

Veeva Quality Docs

Smartsheet

eVAL

Job description

Genentech Oceanside Operations is seeking a Process Validation Engineer to drive PV strategies, author regulatory documents, and ensure cGMP compliance across MSAT initiatives. You will work with cross‑functional teams to maintain schedules, support product transfers, and improve processes through CAPAs and data‑driven reviews.

The role emphasizes hands‑on PV execution, quality systems, and use of digital tools like Veeva and Smartsheet to streamline documentation and reporting.