Contract: MES Engineer / The Netherlands

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