CSV Automation Engineer

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

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 company Standards

Knowledge and Skills

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