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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+