杭州招聘

职位描述：
1. 目的PURPOSE
1.1 明确GMP培训岗位的职责及资质要求
To clearly define the job description and qualification of Associate Director II, PEV Department。
2. 职责DUTY
2.1 汇报范围Scope of the Reporting Structure
2.1.1 Direct supervisor: Senior Director, Process Engineering and Validation
2.1.2 Direct subordinate: Process Engineering Team Leader and Validation Team Leader
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2.2 工作职责Job Responsibility
WuXi Biologics is building a GMP commercial biological manufacturing site.

2.2.1 Manage all aspects of process engineering function during the design, build, and C&Q phases of new Commercial Facility. The scope will include, but not limited to, basic design, detail design, and design/build of upstream and downstream process, and stainless steel media/buffer preparation and hold systems in the biotech manufacturing facility;
2.2.2 Lead the turn-over and training of the facility;
2.2.3 Lead the validation function at new site, Wuxi Biologics.

  ESSENTIAL DUTIES AND RESPONSIBILITIES
2.2.4 Assist site head and department head to oversee the design, construction, commissioning, qualification, and future operation and management of GMP biotech manufacturing facilities.
2.2.5 Manage engineering firm, GC, equipment vendor and consultant to deliver the site project.
2.2.6 Lead validation function to support the design, construction, commissioning, qualification and operation of all GMP facilities of WuXi Biologics;
2.2.7 Lead the management of Commercial Facility process engineering operations;
2.2.8 Establish and maintain cGMP facility management system;
2.2.9 Manage future GMP facility operation to support cGMP production;
2.2.10 Support engineering related audit/visit by clients and regulatory authorities;
2.2.11 Ensures that the design, construction, commissioning and qualification of the Commercial Facility comply with appropriate regulatory requirement and construction code;
2.2.12 Ensures the upper management is well informed on progress of the Facilities;
2.2.13 Other duties assigned by management
3. 人员资质 PERSONNEL QUALIFICATION
3.1 M.S. in chemical engineering and biological engineering discipline with minimum of 15 years of biotech experience in biopharmaceutical process and facility engineering; PhD degree in the same discipline with minimum of 10 years of related experience;
3.2 Hands-on experience in design/build and C&Q of the biopharmaceutical commercial facility;
3.3 Strong collaboration, communication and influence skills;
3.4 Good knowledge and experience in GMP, Quality System, EHS;
3.5 PMP certificate is preferred but not required;
3.6 Proficient in AutoCAD, PLC and P&ID.
3.7 Fluent in written and verbal English communication. 举报 分享

上海药明生物技术有限公司诚聘