Process Validation Engineer

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

The Position

Oceanside Operations (OCN) is a drug substance manufacturing organization dedicated to the reliable production of Roche’s commercial portfolio and pipeline products. Every year, OCN delivers millions of units of life‑saving medicines to patients around the globe by leveraging its two integrated value streams: Stainless Steel and Single‑Use production systems.

As a Process Validation Engineer in our Manufacturing Sciences and Technology (MSAT) group, you will support cross‑functional process validation strategies, lead regulatory documentation efforts, and ensure compliance across site‑specific initiatives. This role serves as a structured professional growth pathway where you will gain hands‑on exposure to core validation methodologies alongside senior engineers while driving continuous process improvements.

The Opportunity

• Author, edit, and execute Process Validation (PV) protocols, execution reports, and regulatory deliverables (such as PPQ OneDoc, PAS, and IMA) in accordance with cGMP standards.
• Perform rigorous compliance and data‑integrity checks on draft validation documents to ensure summary findings and data tables strictly align with raw supporting data.
• Collaborate with the PV Lead to maintain the master schedule and submission filings, actively tracking project milestones.
• Assist with technical activities for product introductions, process transfers, and capacity expansion efforts.
• Facilitate review and approval workflows across cross‑functional teams (Quality, MSAT, Regulatory), keeping partners accountable to project timelines.
• Utilize digital quality systems (Veeva, Smartsheet, AppSheet) to track metrics and streamline documentation workflows.
• Support root‑cause investigations for discrepancies, aiding in the design and implementation of corrective actions (CAPAs).
• Partner with senior engineers to gain hands‑on experience executing equipment qualifications and cleaning validation studies.

Who You Are

• You hold a Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or a related discipline with 4–6 years of relevant industry experience; OR a Master’s degree with 2–4 years of experience.
• You possess practical experience with process validation concepts, technical writing, regulatory submission support, and Quality Systems within a cGMP biopharmaceutical manufacturing environment.
• You have a strong foundational understanding of biopharmaceutical unit operations and process engineering principles.
• You bring exceptional attention to detail with demonstrated skill in technical formatting, compliance checks, and verifying raw source data.
• You are a strong communicator and proactive problem‑solver who thrives when collaborating with cross‑functional and global network partners.

Preferred

• Familiarity with electronic document management systems such as Veeva Quality Docs/RIM, eVAL, or Smartsheet.
• Experience working comfortably within office and cGMP cleanroom environments requiring full gowning.

Work Environment & Physical Demands

• Mix of office and cGMP cleanroom environments.
• Must be able to remain on feet/walk for extended periods (up to 8–10 hours).
• Lift up to 25lbs may be required.
• May work in the clean room environment that requires full gowning (scrubs, coveralls, gloves, safety glasses, and steel‑toe boots); no makeup or jewelry permitted in processing areas..
• Clean room environments feature large mechanical equipment, piping, and pumps connecting to tanks serviced by high‑pressure steam, water and air together this creates a loud environment.
• Work with hazardous materials and chemicals.
• Ability to sit, stand and move within working city for extended periods.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.