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Contract: MES Engineer / The Netherlands

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Added:2021-05-06
Location: Breda, North Brabant, The Netherlands
Salary:Negotiable
Duration:Contract
Apjid3

The client are looking for a MES Engineer based in the Breda Area (Netherlands) on an initial 10 month contract.

Main Responsibilities of the role

  • Provides day to day IS support of the indicated IS systems in support of operations, maintenance and engineering teams under supervision of the system owner.
  • Handling of MES and Packaging Execution Platform related service requests, incidents and change requests.
  • Responsible for the lifecycle management of the indicated IS automation systems
  • Perform analysis and design associated with new requirements.
  • Ensures that all systems are maintained in a quality manner, in compliance with regulations and in alignment with company standards and the network
  • Point of contact for application and infrastructure design
  • Perform testing and develop documentation in support of system changes
  • Mentors and trains department staff members
  • Creates project artefacts according to project requirements
  • Reviews and approves project documentation
  • Develops systems SOPs such as those for maintenance and administration
  • Creates and contributes to development and maintenance of relevant policies, SOPs and associated documents for IS
  • Ensuring compliance with practices, policies, procedures, legal requirements and goals of Site and Corporate sponsors and approved methodologies.
  • Supports, participates in and responds to questions and findings from regulatory and other audits

Desired Experience and Background of the successful candidate

  • Experience with Werum MES, Systech Serialization, OSIsoft PI Data Historian, Oracle, SQL, Unix and Linux
  • Manufacturing automation & IT experience in biopharmaceutical Packaging facilities.
  • Automation and IT technical support of an operating Packaging facility including PLC/SCADA, DCS, MES as well as OEM supplied Automation in a GMP regulated environment
  • Knowledge of Systech Guardian and Advisor software
  • Degree in Computer Science, Information Systems, Engineering, or Life Sciences or equivalent industry experience
  • Minimum 6 years' experience in application development, system administration, or application support
  • Proven experience with Manufacturing Execution Systems and interfaces e.g. OLE for Process Control (OPC)
  • Strong experience in automation or equipment engineering combined with Information Systems (IS)
  • Worked on automation systems in cGMP regulated manufacturing environments, preferably in Packaging
  • Knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation.
  • Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
  • Experience with Product Serialization


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