Role Description: 

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- Reporting to the Digital MMD Project Lead, specifically responsible for OEM & associated CSV scope.
- This candidate will be required to work closely with the Digital MMD teams responsible for the full
Automation and IT scope and with vendors / partners with responsibility for delivery of PLC/SCADA
Element of OEM Systems.

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Role Functions: 

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- Partner with local site project teams to scope changes on the PLC system
- Maintain Inventory and control upgrades to PLC/SCADA systems
- Follow the SDLC Procedure to implement changes (covering RS updates, RTM Change control,
Implementation and test)

SDLC common tasks but not limited to:
- To prepare and approve Quality assurance plans and close out reports
- To partner with local site project teams to scope changes and prep relevant documentation
- In protocol generation, execution and approval
- In the review and approval of automation documents
- Support Field testing Equipment and support commissioning
- Ensure implement is implemented in a safe fashion with quality a necessary output.
- Use and update of development system if required
- Educate local project teams on automation standards as they relate to technology selection, system
configuration, SDLC, validation, hardware, software environments and business processes.
- 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 IT departments (GIO etc) ensuring standard and secure implementation in line
with MSD Standards

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Knowledge, Skills, Education & Location Requirements:

Required: BS in Engineering, Computer Science, or other technical degree. Training completed in PLC
standard and batch. 3 or more years of experience in PLC application. Proven record of proficiencies
associated with business analysis on small sized projects. 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

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Desired:
- Experience in the commissioning of PLC site at a GMP manufacturing site.
- Technical Leadership experience
- Project management experience
- People Management experience
- Life Science experience
- Experience with any of the following Applications
- Kneat, Siemens WinCC/S7, Aveva System Platform/Intouch, Aveva (OSI) PI, Microsoft 365
products and Windows core

- Experience with any of the following processes:
- WFI Generation & Distribution, Building management systems, Cleaning and Sterilization

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