Process Validation Engineer

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

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.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

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.