Process Validation Engineer - Biopharma MSAT

Genentech; Washington; On-site; USD 81,000 - 150,000; Full time

Benefits offered by this job

Discretionary bonus

Benefits package

Job summary

Genentech is seeking a Process Validation Engineer within the MSAT group to support cross-functional PV strategies, lead regulatory documentation, and ensure compliance across site initiatives. You will gain hands-on exposure to core validation methods while partnering with senior engineers to drive improvements.

The role emphasizes collaboration with Quality, MSAT, Regulatory teams, and the use of digital systems for documentation workflows, with a path for professional growth in a regulated

Qualifications

• Degree with relevant industry experience in cGMP biopharma manufacturing.
• Experience with process validation concepts, regulatory submissions and Quality Systems.
• Strong formatting and data-checking skills, attention to raw data provenance.

Responsibilities

• Author/edit PV protocols, execution reports and regulatory deliverables per cGMP.
• Perform compliance/data-integrity checks aligning findings with raw data.
• Maintain master schedule and manage submission filings with PV Lead.
• Support product introductions, transfers and capacity expansion work.

Skills

Process validation

Technical writing

Regulatory submissions

Quality systems

Biopharma operations

Process engineering

Attention to detail

Education

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

Master's degree (optional) in related discipline

Tools

Veeva Quality Docs

eVAL

Smartsheet

Job description

Genentech is seeking a Process Validation Engineer within the MSAT group to support cross-functional PV strategies, lead regulatory documentation, and ensure compliance across site initiatives. You will gain hands-on exposure to core validation methods while partnering with senior engineers to drive improvements.

The role emphasizes collaboration with Quality, MSAT, Regulatory teams, and the use of digital systems for documentation workflows, with a path for professional growth in a regulated