Our client a leading pharmaceutical company based in Mayo, is recruiting for a Serialisation Project Engineer.
This role will involve supporting Serialisation (Track & Trace) initiative by managing the introduction of serialised enabled packaging equipment to a highly automated GMP Pharma environment. The engineer will be responsible for developing a project plan for the procurement, installation and validation of new Track and Trace equipment. The engineer will liaise with Operations, QA, EHS and the equipment vendor to develop the equipment specification and deliver a functional compliant solution to meet with the latest Track and Trace regulatory requirements
Delivery of multiple projects to time plans, cost, quality and safety.
Responsible for the design & installation of new and upgraded packaging equipment with serialisation and aggregation capability.
Responsible for vendor management during all phases of the project to ensure design, schedule and cost adherence.
Travel to vendor site for design review and FAT.
Responsible for vendor/contractor management at site during the install and commissioning phase to ensure systems are installed in a safe and compliant manager
Liaise with IS to enable system connectivity to site DB, SAP and external data repository providers for product data import and export.
Liaise with the Validation and QA department to ensure the system meets operational requirements from a quality, functionality, efficiency and safety perspective.
Responsible for the transition of equipment from qualification phase to operational phase providing technical support as required to operations during the hand over period.
Produce relevant documentation and project update reports to project manager as required to communicate project status,
Education and Experience
Third level qualification in an Engineering or Science or equivalent discipline/experience
Experience of working within either the medical device or pharmaceutical industry would be an advantage but not necessary.
Minimum of 3 to 5 years’ experience.
Project Management experience is preferable but not necessary
Ability to work within a team and on own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.
Can establish good working relationships with key contact members within the organisation.
Good communication and presentations skills, both written and oral – ability to present production data in a clear and concise manner to team members and managers
Good analytical skills and ability to plan and schedule.
Identify and understand issues, problems and opportunities whilst providing a viable solution.
Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
Has high energy, maturity, and ability to work under pressure and deliver results.
Be receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
For further information on this Engineer role in Mayo please contact Caroline Kingston on 0868395531/ email@example.com
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