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MES Integration

  1. Central Germany
Freiburg ( Elbe)
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
35733
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MES Integration PM - Freiburg - 12-Month Contract

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing nearly 200 different medicines and vaccines healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Our purpose is grounded in our belief that all people deserve to live healthy lives. This drives our desire to provide medicines that are safe and effective.



Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • 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
 

Desirable Experience:
  • 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.
  • Previous project management experience
  • 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 Siemens OpsCenter
  • 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
  • Fluent in German

If this role is of interest to you, please apply now! 

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