Your vision. Our solutions.Boxmeer, Netherlands
CSV Engineer
About
- Reporting to the Digital MMD Project Manager, specifically responsible for the Technical Analysis of
- Automation/IT deliverables and their Computer System Validation effort on Projects
- This candidate will be required to work as an integral part of the Digital MMD team, responsible for the
- full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
Responsibilities
- The CSV/Automation Engineer is responsible for activities that include the following:
- Prepare and approve Quality assurance plans and close out reports
- Partner with local site project teams to scope changes and prep relevant documentation
- Protocol Generation execution and approval inside the electronic validation system
- Review and approve automation documents
- Field testing Equipment and support commissioning
- Maintain Inventory and control upgrades to PLC/SCADA/DCS systems
- Use and update of development system if required
- Ensure SLA’s are in place for OEM systems with appropriate support available as back-up if necessary
- Build and maintain relationships with key OEM vendors ensuring reliability of supply and cost effective
- support model
- Partner with internal Digital departments ensuring standard and secure implementation in line with MSD
- Standards
- Knowledge, Skills, Education & Location Requirements
Requirements
- BS in Engineering, Computer Science, or other technical degree.
- Experience in operating automated systems understanding the automation fundamentals.
- Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles.
- Excellent facilitation, problem solving, and decision making skills.
- Demonstrated ability to analyze and define business problems, develop business cases, and identify
- appropriate process and technological solutions is essential
- Experience in integrating vendor packaged equipment into a site digital landscape.
Nice to have
Experience in the commissioning of PLC/DCS’s systems at a GMP manufacturing site.
Kneat electronic validation system experience.
FAT experience at Vendor’s site.
Start
Immediate2 weeks notice1 month notice
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