Equipment Project Engineer
My client is looking for an Equipment Project 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 program 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 ofmanaging full project cycle with knowledge ofspecification, design, and support through to successful conclusion.
* Proven ability to effectively lead cross-functional project teams.