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My client is looking for an Equipment Engineer to join their plant in Limerick.
- Manage the assigned equipment engineering and procurement packages and deliver to plan.
- Monitor during the lifetime of the project.
- Deliver each package within budget.
- Monitor the suppliers during the equipment build.
- Manage all relevant technical reviews during the project.
- Organise and perform Factory Acceptance Testing and Site Acceptance Testing.
- Preparation and execution of all commissioning and validation documentation.
- Manage all training related activities.
- Manage and perform: Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification.
- Manage Validation Sign-Offs.
- Manage the preparation and delivery of all manufacturing documentation.
- Manage and deliver the hand-over of equipment to production.
- Manage customer and stakeholder expectations.
- Maintain appropriate project communication, including progress and financial reporting.
- Leadership of cross-functional project teams.
- Adherence to company's Standard Operating Procedures (SOPs), and industry standards (e.g. GAMP 4).
- Change Management.
- Manage project risks and issues proactively to ensure programme and budget are achieved.
- Degree in an Engineering discipline.
- Minimum of 3 years project engineering/project management experience preferably within a manufacturing environment.
- Working knowledge of project planning software (e.g. MS Project) and Microsoft Office tools.
- Excellent documentation /report writing skills - author and execute validation documentation.
- Thorough working knowledge of process equipment validation (FDA CFR820) and GAMP.
- Desirable Structured problem-solving methodologies - Six Sigma Green or Black belt Waste reduction methodologies - Lean principles, SMED.
- Experience of managing full project cycle with knowledge of specification, design, and support through to successful conclusion.
- Proven ability to effectively lead cross-functional project teams.