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Roche
Roche
H1B Visa SponsorConsultingFood & BeverageHealthcare
Roche is a global healthcare company combining pharmaceutical research and development with diagnostic testing and digital health. Its work focuses on improving patient outcomes through earlier detection, more targeted treatments, and science-led innovation, including AI-enabled tools. The company develops solutions for complex diseases such as cancer and neurological conditions while working with healthcare systems, research partners, and other stakeholders around the world.
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Process Validation Engineer – Oceanside, CA (Onsite)

Support Genentech’s biopharmaceutical manufacturing operations through process validation, cGMP documentation, process transfers, and equipment qualification activities. The role focuses on regulatory deliverables, data integrity, cross-functional coordination, and continuous improvement.

USUnited StatesCACalifornia
$80,500 – $149,500 / year
On-siteFull-timeJuniorMiddleEnglish RequiredEngineer

Description

  • Create, revise, and execute process validation protocols, reports, and cGMP regulatory deliverables, including PPQ OneDoc, PAS, and IMA.
  • Review draft validation documents for compliance and data integrity, reconciling findings and tables with source data.
  • Coordinate with the PV Lead on master schedules, submission filings, and milestone tracking.
  • Contribute technical support to product launches, process transfers, and capacity expansion projects.
  • Coordinate review and approval processes among Quality, MSAT, and Regulatory teams.
  • Use Veeva, Smartsheet, and AppSheet to monitor metrics and improve documentation workflows.
  • Assist with discrepancy investigations, root-cause analysis, and CAPA activities.
  • Work with senior engineers on equipment qualification and cleaning validation studies.
  • Contribute to cross-functional validation strategies, regulatory documentation, compliance activities, and process improvements.

Requirements

  • Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or a related field plus 4–6 years of relevant industry experience, or a master’s degree plus 2–4 years of experience.
  • Hands-on knowledge of process validation, technical writing, regulatory submission support, and Quality Systems in a cGMP biopharmaceutical manufacturing setting.
  • Working knowledge of biopharmaceutical unit operations and process engineering fundamentals.
  • High attention to detail, including technical formatting, compliance review, and source-data verification.
  • Effective communication and proactive problem-solving skills for collaboration with cross-functional and global partners.
  • Familiarity with electronic document management platforms such as Veeva Quality Docs/RIM, eVAL, or Smartsheet.
  • Experience working in office and cGMP cleanroom settings that require full gowning.
  • Ability to stand or walk for extended periods, including up to 8–10 hours.
  • Ability to lift up to 25 pounds.
  • Ability to work in cleanroom environments requiring full gowning.
  • Ability to work with hazardous materials and chemicals.
  • Ability to sit, stand, and move around the work area for extended periods.

Benefits

  • A discretionary annual bonus may be offered based on individual and company performance.
  • Benefits are described at the provided link.
  • Relocation assistance is not available for this position.

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