Lead Process Project Engineer

IrishJobs

Cork, Cork, Ireland

Cork, Cork, Ireland

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Summary: Our client is seeking a Process Project Engineer who will act as the Lead Engineer and SME (Subject Matter Expert) in the Prep and Filling phase for the sites Capital Projects department, as well as acting as a senior project engineer for various other projects. Responsibilities: Develop URS (User Requirements Specifications) & SOWs (Scope of Works) for the Production & Process area as required for Capital Projects. Engage with, and manage design consultants to ensuring they deliver and meet requirements such as: SOWs URS (User Requirements Specifications), agreed budgets, schedules and deliverables. Responsible for review and approvals of all Engineering documentation by the design consultant for their associated area of responsibility. Develop IFB (Issue for Bid), IFT (Issue for Tender), work packages for vendors & contractors applicable to the scope of Utilities projects. Support the Capital Projects to deliver projects on time and in accordance with agreed key milestones for a project or portfolio of projects for the site. Responsible for the process design and may have ownership of sub packages associated with the process equipment. Communicate the status of all projects to all relevant stakeholders and shall provide updates on Capital Project. Manage construction work associated with projects. Responsible for implementing projects in line with company validation procedures. Responsible for developing cost estimates. Responsible for developing a URS, Scope of Work documents for projects and ensuring that they are signed off by all stakeholders and then issued to design consultants & vendors. Responsible for developing and managing a project schedule. Responsible for construction works. Ensuring contractors who will be onsite will be compliant with regulations and site safety requirements, documentation, and responsible for contractor works while onsite. This consists of but not limited to ensuring AF1 & AF2 forms submitted, PSDS & PSCS allocated, RAMS submitted and reviewed, and work carried out is permits are signed and supervised, along with overall oversight of construction tasks applicable to project engineer owned projects. Responsible for developing a cost estimate in line with CAR requirements, and ensuring projects are kept within approved budgets, management of purchase orders, and invoicing. Participate & chair lessons learned workshops and project closeout. Preparing for and attending Factory Acceptance Tests (FATs), and Site Acceptance Tests (SATs). Qualifications & Experience: Mechanical or Process & Chemical Engineering qualification, with ten (10) years previous Pharmaceutical & Medical Devices experience leading and implementing Utility based Capital Projects for a site; Experience in the delivery of process related projects in a Pharmaceutical & Medical Devices environment with a strong mechanical focus. Experience as a change manager in developing and implementing new and /or improved Capital Projects Engineering management processes and procedures for a site; Experience in managing a range of suppliers e.g., design, construction, equipment, professional services etc.; Experience in managing change with respect to projects and scope changes procedures. Experience in project and construction management; Experience in developing a strong working relationship with teams and cross functional departments internally and externally. Specific experience in Campaign Filling and Powder Transfer Systems is desirable Knowledge of Trackwise Digital, Kneat, Veeva and Hexagon is desirable.

TLNT1_IJ

Cork, Cork, Ireland

Sprachkenntnisse

English

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