MES Engineer

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  • Dienstverband Fulltime
  • Vacaturenummer VAC-10002615
  • Locatie Breda
  • Contract secondment via YER

Over deze vacature

For AMGEN in Breda, we are looking for a MES Engineer for the IS team.

Functie

Objectives

  • To provide technical leadership for Manufacturing Execution System (Werum PAS|X, ADTM Application), Product Serialization System (Systech) components and MES to ERP (SAP) and interfaces to level 2 automation systems for Commercial and Clinical.
  • To develop, maintain and operate new and existing services in support of site operations

Bedrijf

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Aanbod

  • Good employee benefits (e.g. work-life balance, pension, lease car, bonus model)
  • Challenging assignments
  • Excellent guidance from your consultant and YER's back office
  • Development opportunities, including the YER Talent Development Programme with a personal coach
  • Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance)
  • Cooperative and results and relationship-driven
  • Friendly atmosphere and open culture
  • Community/network with other technology professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies
  • Possibility to receive a fixed contract after 6 months directly with the client.

Profiel

  • Degree in Computer Science, Information Systems, Engineering, or Life Sciences or equivalent industry experience
  • Bachelor's Degree and 6 years of experience with MES and Packaging Execution Systems
  • Minimum Requirements
  • 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
  • Experience with Windows Server 2008, 2012 and 2016
  • Ability to understand and apply corporate blueprint and standards using business drivers to local business needs and requirements
  • Ability to communicate ideas in both technical and user-friendly language
  • Able to recognize problems and communicate solutions conceptually
  • Fluency in written and spoken English
  • Willing to work outside office hours on-call
  • Preferred Requirements:
  • 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
  • Knowledge of Amgen processes and technical standards
  • Knowledge of ITIL framework (ITIL v3)
  • Experience in working in global Pharmaceutical or biotechnology environments
  • Competencies
  • Demonstrates service oriented attitude
  • Excellent organisation skills, detail oriented and accurate
  • Skilled in working under pressure; must possess good time management skills
  • Proven analytical and problem-solving skills
  • Skilled in working effectively in a team matrix environment
  • Excellent communication and presentation skills
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