Biopharma Process Validation Engineer – GMP & PV Expert

F. Hoffmann-La Roche AG; United States; Hybrid; USD 81,000 - 150,000; Full time

Job summary

Genentech, a Roche subsidiary, seeks a Process Validation Engineer to lead PV protocols, regulatory deliverables, and data-integrity checks within the MSAT group. You will collaborate across Quality, MSAT, and Regulatory teams to ensure compliant, timely study execution and documentation.

You will support product introductions, process transfers, and capacity expansion while utilizing Veeva and Smartsheet to track metrics and maintain the master schedule.

Qualifications

• Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or related discipline; Master’s degree with 2–4 years’ experience also acceptable.
• Experience with process validation concepts, regulatory submission support, and Quality Systems in cGMP biopharmaceutical manufacturing.
• Strong attention to detail with expertise in technical formatting, compliance checks, and validating raw data.
• Excellent communication and proactive problem-solving skills for cross-functional collaboration.

Responsibilities

• Author, edit, and execute PV protocols, execution reports, and regulatory deliverables (e.g., PPQ OneDoc, PAS, IMA) per cGMP.
• Perform compliance and data-integrity checks to ensure alignment with supporting data.
• Maintain master schedule and submissions filings; track project milestones with PV Lead.
• Assist with product introductions, process transfers, and capacity expansion.
• Facilitate review workflows across Quality, MSAT, Regulatory; ensure timelines.
• Use digital quality systems (Veeva, Smartsheet, AppSheet) to track metrics and streamline docs.
• Support root-cause investigations and CAPA implementations.
• Collaborate with senior engineers on equipment qualifications and cleaning validation.

Skills

Process validation concepts

Technical writing

Regulatory submission support

Quality systems

Cross-functional collaboration

Veeva/Smartsheet/AppSheet experience

Education

Bachelor’s degree in Chemical Engineering/Bioengineering/Life Sciences

Master’s degree with 2–4 years experience

Tools

Veeva Quality Docs/RIM

eVAL

Smartsheet

AppSheet

Job description

Genentech, a Roche subsidiary, seeks a Process Validation Engineer to lead PV protocols, regulatory deliverables, and data-integrity checks within the MSAT group. You will collaborate across Quality, MSAT, and Regulatory teams to ensure compliant, timely study execution and documentation.

You will support product introductions, process transfers, and capacity expansion while utilizing Veeva and Smartsheet to track metrics and maintain the master schedule.