Process Validation Engineer
About 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.
Requirements
- 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.
- Practical experience with process validation concepts, technical writing, regulatory submission support, and Quality Systems within a cGMP biopharmaceutical manufacturing environment.
- Strong foundational understanding of biopharmaceutical unit operations and process engineering principles.
- Exceptional attention to detail with demonstrated skill in technical formatting, compliance checks, and verifying raw source data.
- Strong communicator and proactive problem-solver who thrives when collaborating with cross-functional and global network partners.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are not available for this posting.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
