This is an 11 month contract
The OEM Area lead will drive the development and provision of all associated OEM Systems /Equipment. Manage the Design and development of OEM hardware and Software Components, and other hardware devices required in manufacturing building or support areas. Working with peers in the manufacturing business to understand and capture their user requirements and assist in the provision of same. • Liaise with the global COE teams to ensure the company’s standards are understood and communicated to system integrators and vendors.
• Project Planning, and adherence to schedule in conjunction with the Scheduler and Workstream Leads
• Utilisation of Project management tools including Risk, Issue, Action and Decision management
• Ensure the appropriate quality documents as needed for the Life-Science industry, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place, and are aligned with the qualification strategy of the project
• The candidate will be required to work closely with team members both global and local, having responsibility for the full OEM scope, and liase with vendors and partners on the delivery of systems
• The candidate will review and ensure vendors compliance with the company’s quality standards.
• Develop and/or review SDLC deliverables, compliant with the company’s standards, including but not limited to:
Requirements Traceability Matrix
Test specification/test script
• Work closely with vendors of OEM equipment to ensure deliverables meet project requirements, including the interfacing of new OEM equipment with existing site systems, incl. MES and Pi Historian.
• Work closely with the QAIT function and ensure their requirements are met in all deliverables.
• Participate in Hardware and Software FATs and SATs.
• Provide input to the development of project schedules and document trackers.
• Participate in, and support, relevant project meetings.
• Liaise with stakeholders on the overall project to ensure clear communication between all parties.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Relevant Computer Science/Engineering degree or equivalent
• Minimum of 5 years’ experience in a similar role, ideally in the pharmaceutical industry.
• Fluent in English, written and verbal.
• Strong experience in one or all the following systems: Siemens PLCs, HMIs and OPC Communication protocols and Historian Software.
• Strong knowledge of project lifecycle and associated deliverables for automation systems
• Excellent computer skills, proficient in the use of the following Microsoft tools: Word, Excel, PowerPoint, Viso, MS Project and Agile PM tools.
• Strong interpersonal and communication skills (verbal and written).
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