secondment via YER
Over deze vacature
For AMGEN in Breda, we are looking for a MES Engineer for the IS team.
- 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
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.
- 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.
- 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
- 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