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Our client, a leading biopharmaceutical organisation based in Waterford, is seeking an Equipment Project Engineer to deliver a portfolio of capital and automation-related projects across manufacturing and operational areas, including biologics, oral dosage, medical devices, laboratories, and packaging. The successful candidate will manage projects end-to-end, ensuring delivery in line with schedule, cost, quality, and scope requirements, while collaborating with cross-functional teams and external partners to support equipment upgrades, system implementations, and operational improvements within a GMP-regulated environment.
Responsibilities:
- Deliver multiple Automation Related projects, primarily virtualisation of servers associated with live production equipment. Deployment will occur in defined shutdowns requiring excellent co-ordination.
- Management of multiple groups, Global & local ITS teams, Automation, Validation and Production teams along with specialist external contractors.
- Develop solutions along with Original Equipment Manufacturer (OEM) to upgrade control systems.
- Provide automation support and expertise in the procurement, build, commissioning and qualification of GMP equipment.
- Working in team environment on several projects deployed in a phased nature.
- Deliver on packaging, serialisation & aggregation biopharmaceutical equipment project portfolio within our client’s biopharmaceutical operations which include enzyme, monoclonal antibodies (mAbs), oral dosage, medical device, laboratories & packaging operations.
- Perform procurement, acceptance of equipment & associated infrastructure on behalf of client and report regularly on project status throughout the project lifecycle. Management of end-to-end project lifecycle is key to success.
- Ensure compliance environmental, health and safety codes practices, approved project KPIs, performance standards and specifications are maintained.
- Liaise with external and internal customers, suppliers, and vendors to define and deliver right first-time project deployment.
- Chair and Interaction with assigned project teams to interpret their requirements and ensure approval to align project scope as requested.
- Assign responsibilities, mentor project team and maintain accurate project planning documentation as defined by the client the stage gate model for project delivery.
- Communicate effectively with weekly reports to management and senior stakeholders.
- Support to other project participants to overcome obstacles when they present themselves.
- Review engineering deliverables, initiate site change controls and associate documentation required by the project life cycle. xcfaprz
- Responsible for delivering performance metrics for budget, schedule, scope and quality adherence.
Qualifications & Experience:
- Degree in Mechanical, Chemical, Industrial, or a related Engineering discipline (Master’s degree or relevant project management certification is advantageous)
- Minimum 10 years’ experience in project engineering or project management roles within a regulated environment
- Strong experience working within a cGMP pharmaceutical or biopharmaceutical environment
- Proven experience managing capital projects and equipment-related initiatives
- Strong knowledge of automation systems and control system upgrades
- Experience supporting equipment procurement, commissioning, and qualification processes
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Languages
- English
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