Lead Process Utilities Project Engineer

3 days ago

Cork, Ireland Tandem Project Management Limited Full time

Summary: A Project Lead (Utilities) is required for our client, a pharmaceutical company based in Cork who will provide process utilities expertise to projects on site. This role will focus on aspects relating to clean utilities system design, construction, and commissioning as well as providing technical support. Responsibilities: Act as the lead engineer and SME (Subject Matter Expert) in the process utilities area for the site, as well as acting as a senior project engineer for the sites Capital Projects department. Develop URS (User Requirements Specifications) for the clean utilities systems required for associated projects as well as supporting the development of URS for the solution preparation systems. Engage with and manage design consultants, trade contractors and work package equipment suppliers to ensuring they deliver and meet requirements such as: URS (User Requirements Specifications), agreed budgets, schedules, and deliverables. Responsible for review and approvals of all Engineering documentation by the design consultant design consultants, trade contractors and work package equipment suppliers for their associated area of responsibility. Develop Issue for Bid (IFB), Issue for Tender (IFT), Issue for Purchase (IFP), work packages for vendors & contractors applicable to the scope of process utilities. Responsible for performing technical bid analysis and commercial bid analysis for their associated area of responsibility. Contribute to the delivery of projects on time and in accordance with agreed key milestones for a project or portfolio of projects for the site. Provide assistance and technical input into the preparation of other discipline design packages that have process utilities elements or interfaces. Provide assistance and technical input into the preparation of solution preparation design packages. Effectively communicate the status of all projects to all relevant stakeholders and shall provide updates. Manage construction work associated with their work packages. Responsible for implementing projects in line with validation procedures. 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. Responsible for various other projects as required by the site. Responsible for preparing for and attending Factory Acceptance Tests (FATs), and Site Acceptance Tests (SATs) associated with their areas of responsibility. Responsible for the management, training, and development of graduates. Qualifications & Experience: Engineering Degree in in Process Engineering, Mechanical Engineering or similar discipline. At least 10 years experience working in a Pharmaceutical & Medical Devices GMP Environment and implementing Capital Projects Management for a site. Detailed knowledge of pharmaceutical water generation and distribution systems e.g. Water pre-treatment Systems, Reverse Osmosis (RO) Water Systems, WFI system, Clean Steam systems. Good understanding of process engineering aspects associated with solution preparation within a fill finish plant. Experience in the development of Capital Project Engineering processes and procedures and the delivery of the same to agreed key milestones in the Pharmaceutical & Medical Devices industry. 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. Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook). Skills: GMP Capital Projects Management Reverse Osmosis Water System WFI system Clean Steam systems

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