东莞招聘

岗位职责： 项目阶段：
1. 协助设计团队设计生产运行中用到的所有设备，支持运行准备工作，包括工作危险分析，工艺流程，标准操作程序，培训，制造执行系统（PMX）等。 2.协助认证，采购工艺设备
3. 协助相应范围内设备的授权，质量工作，包括文件审核，工厂验收测试，在场验收测试等
4. 协助性能认证，运转准备工作，包括文件审核，模拟实验，工艺认证。
5. 审核驻场流程，新建工厂培训。
运行阶段：
1. 监控空并建立有效的安全体系
2. 参与月度健康安全环境演练
3. 完成设备工作和转动记录表
4. 负责运行主管不在现场时的工作
5. 确保流程根据既定的工艺程序进行
6. 为生产装液体药品的圆柱状管的运作者提供专业协助
7. 与质量和技术人员沟通，解决运行问题
8. 认证运行提升并协助执行（工艺，设备等）
9. 主动监控文件和生产质量
10. 负责设备运行
11. 再审批生产记录，根据命令执行批量发放记录，达到OSSCE标准
12. 维护SAP系统，负责协调
13. 确保轮班沟通顺利，完成交班工作报告
14. 及时向上级汇报所有质量问题
15. 在线运作人员的培训
16. 协助运作文员中作评估报告
17. 第1阶段生产工作审查，确保10天内审核通过
18. 主要在生产线上轮班工作


岗位要求：
1. 制药相关专业本科及以上学历；
2. 5年及以上制药企业工作经验；
3. 胰岛素制药（胰岛素优泌乐与优泌林溶液、悬液）的相关经验；
4. 具有GMP认证经验，熟悉认证实行过程中生物制药的工艺流程、设备和器材等；
5. 熟知清洁设备验证（包括擦拭和漂洗设备）和取样技能；
6. 熟悉Atech设备；
7. 较强的协调、沟通及文字表达能力；
8. 能够带领团队、培训相关人员；
9. 英语书面及口语表达熟练；
10. 对自动化工作充满兴趣，良好的团队合作能力，独立自主的工作能力；
11. 能够接受出差；
12. 了解功能性安全者优先。


Main role description:
Project Phase (Design / Commissioning and Qualification Period:
1. Assist the design team in designing the facility and production process, with focus on all operational aspects of the process, including development of JHAs, Process flows, SOPs, Training, MES (PMX) Tickets, etc to support the operational readiness effort.
2. Assist in identifying and purchasing of miscellaneous support equipment for the process.
3. Assist in the commissioning and qualification of area equipment, including, but not limited to, document reviews, factory acceptance testing, and site acceptance testing.
4. Assist in the performance qualification / commercial readiness activities including, but not limited to, document reviews, media fills, water fills, and process validations.
5. Training and learning the new process through review of replication site procedures, and training at the Greenfield facility.
Operational Phase:
1. Monitor and build a strong safety culture
2. Participate in monthly HSE walkthroughs
3. Ensure Stretching and Rotation log is completed.
5. Responsible for supervision of operators on the production floor when Operations Leader is off the floor
6. Ensure that operations are conducted according to established procedures
7. Provide expertise and assistance with the cartridge manufacturing process to operators
8. Resolve operational issues on shift, which may include frequent communication with quality and technical resources
9. Identify opportunities for operational improvements and assist in implementation (e.g., procedure, equipment or ticket changes)
10. Proactively monitor documentation and product quality; Perform the duties of an operator to be qualified on and help run equipment
11. Perform batch record review and support batch release following order completion to meet OSSCE standards
12. Maintain SAP staged inventory and perform transactions to reconcile
13. Ensure shift report is completed daily by shift’s end ; Ensure good shift communication occurs between outgoing and oncoming shifts
14. Ensure all quality events are reported to supervision immediately
15. Ensure operators are trained and qualified for duties they perform on line
16. Assist in the completion of Performance Assessments for operators
17. Level 1 events investigated and approved within 10 calendar days of event origination
18. Spend 90% of each shift on the production line.


Responsibilities:
1. Degree in Pharmaceutical (minimum Bachelor degree)
2. 5 years of experience in pharmaceutical companies
3. Experience with insulin products (Humalog and Humulin solutions and suspensions)
4. Experience with GMP regulated environment and a high level understanding of bio-pharmaceutical processes, equipment and facilities with demonstrated advanced knowledge of validation execution
5. Knowledge in Bosh Packaging system is a plus
6. Good communication skills
7. Ability to lead a team and have experience in project management
8. Ability to train people
9. Good English (spoken & written)
10. Personality: enthusiast, passionate towards automotive; team player, proactive, able to learn quickly and to think independently
11. Willing to travel
12. Knowledge of functional safety(PPE)

Capgemini Engineering凯捷科技研发是全球工程研发 (ER&D) 服务的企业合作伙伴，基于其在数字化和软件领域的深厚行业知识及前沿技术积累，凯捷科技研发赋能客户实现数字世界和现实世界的融合，并结合集团其他部门的能力，加速其产业智能化的发展步伐。凯捷科技研发现有超过55,000名工程师和技术专家，遍布全球30多个国家，服务于航空、航天、国防、海军、汽车、铁路、基础设施与交通、能源、公用事业与化工、生命科学、通信、半导体与电子、工业与消费、软件与互联网等产业。

Capgemini Engineering是凯捷集团必不可少的一部分。凯捷是全球知名的企业合作伙伴，利用技术的力量改造和管理企业业务。其宗旨是通过技术释放人类能量，创造一个包容和可持续的未来。凯捷是一个负责任的多元化组织，在50余个国家拥有超过34万名团队成员。凭借其55余年的悠久历史和深厚的行业专业知识，在快速发展的云、数据、人工智能、互联连接、软件、数字工程和平台的创新世界推动下，凯捷深受客户信任，能够满足客户从战略、设计到运营的多方位业务需求。集团2021年全球收入为180亿欧元。