Summary: 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 clients biopharmaceutical operations which include enzyme,monoclonal antibodies(m Abs), 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.
Responsible for delivering performance metrics for budget, schedule, scope and quality adherence.
Qualifications & Experience: Degree in Mechanical, Chemical, Industrial, or a related Engineering discipline (Masters 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 c GMP 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