Duration 12+ Months

Role Description

• 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.

Role Functions

(Functions include, but are not limited to, the following)
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

Required:
• 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.
Desired:
• 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.

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