Production Process Engineer

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position1. 生产运行与倒班管理 / Production Operation & Shift Management 负责高活口服固体制剂车间(SHiP II)的日常生产协调与组织。合理调配人力与设备资源以高效执行生产计划，确保所有现场操作严格遵守cGMP和标准操作规程（SOP）。全面参与并管理班次生产线，执行现场操作巡检、车间查核、考勤管理及生产辅助用品的管控。制定并落实员工守则，维护安全、有序的现场生产环境。 Coordinate and organize daily production activities in the highly potent Oral Solid Dosage (OSD) workshop (SHiP II). Appropriately allocate labor and equipment resources to efficiently execute the production plan, ensuring all on-site operations strictly comply with cGMP and SOPs. Fully participate in and manage the shift production line, executing on-site operations inspection, shop floor audits, attendance management, and auxiliary supplies control. Formulate and implement staff rules to maintain a safe and orderly on-site production environment. 2. 生产问题的解决 / Troubleshooting of Production Issues 深刻理解制药技术及端到端（E2E）系统影响，与各支持部门密切合作，为设备及产品生产过程中出现的突发异常提供快速排故与解决方案。具备前瞻性，及时发现潜在问题并采取预防措施；在解决生产问题的同时，能够准确评估所采取行动对其他人员或系统的影响，并为管理层决策提供专业的信息支持。 Understand pharmaceutical technology and end-to-end (E2E) process impacts deeply, working closely with support groups to rapidly troubleshoot and provide solutions for unexpected equipment and production process issues. Anticipate potential problems and take preventative actions. While resolving production issues, accurately assess how own actions impact others or other systems, using this information to provide professional support for management decision-making. 3. 质量控制与合规 / Quality Control & Compliance 严格贯彻罗氏集团质量标准，确保生产全环节符合国家cGMP法规及公司政策要求。主导并参与车间生产变更与偏差的管理，制定切实有效的CAPA（纠正与预防措施）并及时追踪闭环。负责主导或参与内部及外部官方质量审计的准备工作，并在现场提供专业的应对与支持。 Strictly implement Roche quality standards and ensure all production stages comply with national cGMP regulations and corporate policies. Lead and participate in workshop change and deviation management, formulate effective CAPAs (Corrective and Preventive Actions), and track their timely closure. Take charge of or participate in preparations for internal and external regulatory quality audits, providing professional on-site response and support. 4. 文件、数据与信息化管理 / Documentation, Data & IT System Management 负责车间内SOP等各项生产操作规程及工艺文件的起草、修订、定期回顾与全生命周期的更换管理。熟练操作SAP、MES、Veeva及Cornerstone等信息化系统。填写、复核生产批记录及运行日志，审核文件及相关数据计算，确保所有纸质及电子数据严格符合数据完整性（DI）要求。 Responsible for drafting, revising, periodically reviewing, and managing the full lifecycle replacement of SOPs and technical documents within the workshop. Proficiently operate SAP, MES, Veeva, Cornerstone, and other IT systems. Complete and review production batch records and logbooks, check documentation and related calculations, ensuring all paper and electronic data strictly meet Data Integrity (DI) requirements. 5. 工艺管理 / Process Technology Management 参与新产品试制与新工艺的导入转化。与MSAT（制造科学与技术）团队紧密合作，以高度的独立性与专业胜任力，执行相关工艺验证、清洁验证以及设备的确认的生产支持性工作，确保持续的工艺稳健性和符合性。 Participate in new product trials and technology transfers. Work closely with MSAT (Manufacturing Science and Technology) and validation teams with high independency and competence to support and execute process validation, cleaning validation, and equipment qualification. Ensure continuous process robustness and manufacturing process compliance. 6. 设备运行与维护 / Equipment Operation & Maintenance 负责口服固体制剂及包装生产线设备的日常操作、深层清洁、预防性维护支持与模具更换。整合及准备生产设备以确保其随时可用于生产。配合工程团队完成机器设备的安装、调试与成套，使设备始终处于高效的运行与管理状态之中。 Manage the daily operation, deep cleaning, preventive maintenance, and mold replacement of OSD and packaging line equipment. Assemble and prepare equipment to ensure it is ready for production at all times. Cooperate with technical and engineering teams to complete the installation, commissioning, and setup of machinery, keeping equipment in highly efficient operation and management conditions. 7. 持续改进 / Continuous Improvement 致力于建立和完善生产工作流程的标准化。推动车间现场精益生产系统（LPS）及Kaizen（持续改进）项目的落地实施。通过不断优化工艺流程与操作模式，有效提升OEE（整体设备效率），并实施合理化建议以控制生产预算，降低制造成本。 Dedicated to establishing and improving production workflow standardization. Drive the implementation of the on-site Lean Production System (LPS) and Kaizen (continuous improvement) initiatives. By continuously optimizing process workflows and operating modes, effectively improve OEE (Overall Equipment Effectiveness), and implement reasonable suggestions to control production budgets and reduce manufacturing costs. 8. 人员培训与团队建设 / Personnel Training & Team Building 致力于建立专业、和谐且具有高效沟通氛围的工作团队。主导新员工上岗前的理论与实操考核，并指导下属及一线员工的在岗培训（OJT），提升GMP意识并发展多技能操作能力。负责培训系统内的课程创建，以及培训计划（TP）与岗位职责（JD）的更新与系统导入。 Dedicated to building a professional, harmonious team with an effective communication atmosphere. Lead pre-job theoretical and practical assessments for new operators, and coach On-the-Job Training (OJT) for subordinates and frontline staff to enhance GMP awareness and develop multi-skill operational capabilities. Responsible for course creation in training systems, including updating and importing Training Plans (TPs) and Job Descriptions (JDs). 9. EHS（环境、健康与安全）管理 / EHS Management 遵守公司各项EHS政策与环境准则，针对高活制剂生产特性，切实落实日常作业中的职业危害防护与安全操作。具备前瞻性风险意识，发生人员受伤、职业病、未遂事故（Near misses）及发现安全隐患时须立即上报并提出建议。作为车间包装及生产区域SHE接口人（SPOC），负责安全评估、STARI数据追踪，及现场卫生与虫害控制。 Comply with corporate EHS policies and environmental guidelines. Tailored to highly potent product manufacturing, strictly implement occupational hazard protection and safe operations in daily tasks. Maintain proactive risk awareness; immediately report injuries, illnesses, near misses, and safety hazards, and provide suggestions. Act as the SHE Single Point of Contact (SPOC) for production and packaging areas, responsible for safety assessments, STARI tracking, and on-site hygiene and pest control. 10. 其他工作 / Other Duties 积极配合团队工作，按时且高质量地完成上级领导交办的其他相关工作任务与项目。 Actively cooperate with the team and complete other relevant duties, tasks, and projects assigned by the line manager/supervisor on time and with high quality. Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.