流程验证工程师
Process Validation Engineer
Oceanside Operations (OCN) 是一家专注于罗氏商业产品组合和管线产品的可靠药物活性成分制造组织。通过其两条集成的价值流：不锈钢生产系统和一次性生产系统，每年 OCN 向全球患者交付数百万单位的救命药品。
作为制造科学与技术（MSAT）团队中的一名 **工艺验证工程师**，你将支持跨职能的工艺验证策略，主导监管文件工作，并确保现场特定项目符合规范。这个职位是一个结构化的专业成长路径，你将有机会在资深工程师的指导下，接触核心验证方法并推动持续的工艺改进。
**岗位机会**
- 根据 cGMP 标准，撰写、编辑并执行工艺验证（PV）协议、执行报告和监管交付物（如 PPQ OneDoc、PAS 和 IMA）。
- 对草案验证文件进行严格的合规性和数据完整性检查，确保总结结果和数据表严格与原始支持数据一致。
- 与 PV 主管合作，维护主时间表和提交文件，积极跟踪项目里程碑。
- 协助产品引入、工艺转移和产能扩展相关的技术活动。
- 在跨职能团队（质量、MSAT、法规）之间促进审查和批准流程，确保合作伙伴遵守项目时间表。
- 利用数字质量系统（Veeva、Smartsheet、AppSheet）追踪指标并优化文档流程。
- 支持偏差的根本原因调查，协助设计和实施纠正预防措施（CAPAs）。
- 与资深工程师合作，获得设备确认和清洁验证研究的实际操作经验。
**你具备**
- 化学工程、生物工程、生命科学或相关专业的学士学位，具有 4–6 年相关行业经验；或硕士学历，具有 2–4 年经验。
- 具备在 cGMP 生物制药制造环境中，工艺验证概念、技术写作、监管提交支持和质量体系方面的实际经验。
- 对生物制药单元操作和工艺工程有扎实的基础理解。
查看英文原文
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](https://roche.ehr.com/default.ashx?CLASSNAME=splash)
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](https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform).