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Detailed Job Description:

Responsible for providing technical guidance and support in the execution and delivery of the Manufacturing Execution System (MES). Coordinate and align within the Global MES team and other IT teams involved as well as with the customers Strong experience with MES systems Analysis and solving of technical issues related to the MES system and/or interfaces Direct and manage activities of technical staff on URS/FRS generation, software configuration and coding. A thorough understanding of system cGMP requirements and demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments. Liaise where necessary with MES platform provider, engineering contractor, and equipment vendors on the lifecycle of document preparation, approval, coding, and delivery Assist with Computer Systems Validation (CSV) activities: Validation Plan, Risk Assessment, Protocols, Test Protocols, Change Requests etc. General management and oversight to the MES software documentation effort

Key Requirements:

Bachelor’s Degree in Engineering/ Technology or equivalent experience. A minimum of 3-5 years related work experience with factory automation and equipment integration within the pharmaceutical sector. Substantial experience with design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). Significant experience with MES systems desirable. A thorough understanding of system cGMP requirements and demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments. Passionate about improving the quality of software products Significant experience with MES systems desirable, preferably Rockwell Pharmasuite/ Emerson Syncade/ Weum PAS-X Experience with MES integration other Applications (ERP, preferably SAP) and Laboratory Information Management Systems (LIMS) systems/ Historians OSISoft PI Understanding of system hardware design for PCS and MES Team player with exceptional customer service skills, integrity and ability to interact with all levels of personnel. Requires strong attention to detail and analytical skills as well as problem analysis and resolution. Ability to evaluate solutions and recommend action based on meeting scope, schedule, and budget

Minimum years of experience*: 10+