The 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.

Role Functions:

- 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 company Standards

- Knowledge, Skills, Education & Location Requirements Required:

- BS in Engineering, Computer Science, or other technical degree.

- Training completed in PLC standard and batch.

- 3 + 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

(Parts washers & Autoclaves), Blending and Formulation, Filling, Packaging and Inspection.

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