(资深)包装操作工 - 无菌制剂（正式工）
About this opportunity
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 Position
罗氏正在上海建设全新的大分子工厂。我们开放了包装操作工的岗位，该职位要求具备出色的执行能力和丰富的包装操作经验，精通核心包装流程，并能够操作和日常维护包装设备，以确保生产的连续性和可靠性。此外，该职位还需与项目团队紧密合作，共同执行这项战略计划，包括工厂设计、验证、生产准备和启动等工作。
包装操作工负责在工艺步骤（例如针头切割、贴标和包装）中达成生产目标，确保产品安全、及时地生产，并完全符合GMP/SHE要求以及罗氏的企业原则、质量政策和标准。
负责包装线上相关工艺设备的操作和清洁，包括针头切割机、贴标机、装盒机、药监码系统、装箱机和码垛机。
负责包装物料的转运和管理，包括包装线上的针头检查。
协助进行包装线的设备验证和工艺验证。
负责高质量、高效率地执行资质认证和生产活动。
工程项目支持和运行准备阶段:
参与新厂房的设计和建设，包括但不限于工厂验收测试 (FAT)、现场验收测试 (SAT)、安装运行性能确认 (IOPQ) 等，为项目交付做出贡献。
支持包装工艺的初步开发和优化。
参与运行准备工作的实施，例如：起草设备操作规程和日志、现场5S 管理、根据准备计划进行现场机器清洁等。
接受包装设备操作和 CCS 实施方面的培训并获得相关资质。
完成其他分配的任务。
日常运营阶段:
确保日常操作符合罗氏的GMP/SHE及相关法规要求。
执行以下生产操作：例如，针头切割和目视检查、贴标和包装。
执行常规包装生产操作并填写GMP记录。
确保所有包装活动的数据准确性、完整性和可追溯性。
在包装过程中实施冷链管理。
在维护工程师的支持下，及时诊断并解决设备故障，以最大限度地减少停机时间。
相关IT系统操作，例如SAP、MES。
执行其他分配的任务。
岗位要求：
教育背景/资质
大专及以上学历（药学/生物学专业优先）。
岗位所需胜任力
拥有3年及以上注射剂制药行业运营经验，有跨国生物制药公司经验者优先。
具备包装设施战略项目经验者优先，包括设计、调试和验证。
熟悉cGMP及制药行业相关法规，尤其是生物制药行业相关法规。
能够与团队成员和干系人有效沟通、协作并建立积极的互动关系。具备基本的英语沟通能力优先。
Who we are
A 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.
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 2091 comparable Manufacturing & CMC roles across 134 biopharma companies.
Salary context
598 of 2091 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 2091 comparable roles
+ 46 more countries
Seniority mix
917 of 2091 peers have a known seniority level
Therapeutic area mix
6 of 2091 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.