One of our leading Biotech clients (Fortune Top 150 company) is looking for an MES Automation Engineer in Breda (NL). We are looking for someone who has experience with industrial automation, preferably in pharma/biotech/GMP environments.
In this role as MES Engineer your objectives are 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.
- 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 our standards and the network
- Point of contact for application and infrastructure design
- Perform system maintenance such as application and server patching
- Maintain design and configuration specifications
- Perform testing and develop documentation in support of system changes
- Mentors and trains department staff members
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations
- Translates requirements into technical solutions that meet business needs
- Reviews and approves project documentation
- Develops systems SOPs such as those for maintenance and administration
- Develops SLAs/OLAs as required
- 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 Product Serialization
- Experience with Windows Server 2008, 2012 and 2016
- 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
- Knowledge of Systech Guardian and Advisor software
- Knowledge of ITIL framework (ITIL v3)
9 months (extension options tbd)
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? Check this LINK
For more information please contact Ralph Looijen on +31 (0)20 20 44 502