Website Asset Recruitment
Senior Project Manager
State of the art manufacturing facility, focused on formulating and filling vaccines and biologics products that improve and transform the lives of people across the world.
This individual will be a Senior member of a multi-discipline team, specifically responsible for the delivery to CQ of the project scope for a multi-product aseptic filling facility.
• Define and agree, with Suite Team Leads and the Project Manager, the physical and procedural scope and scope boundaries, within the operating facility footprint.
• Manage those project plans for design, construction, commissioning, qualification schedule and cost in collaboration with sub-project managers (Suite Leads) other senior project team members, operations personnel, together with outside contract and trade partners.
• Lead the development of project plans and successfully execute them according to the established safety, schedule, cost and performance standards.
• Lead and manage scope, budget, schedule, safety, quality and personnel discussions with the Suite Leads of the project.
• In Conjunction with the Suite Leads develop, document, agree and implement an execution strategy to deliver their sub-scopes in a coordinated, controlled and well communicated manner.
• Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
• Facilitate engineering and user requirements for the project Suites.
• Track and report progress as required against project deliverables.
• Foster a strong relationship between the Client Project Team, EPCM Contractor, Site Contractors and strategic vendors to ensure delivery of project.
• Lead and facilitate the coordinated review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Job Specifications, change control processes and PO’s/Data Sheets.
• Facilitate the coordinated development of construction, procurement, C&Q and project control strategies, into plans for the execution of the project.
• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
• A minimum of fifteen years of relevant experience in project management of larger projects in the Pharma industry including significant experience managing biologics/sterile projects.
• Technical knowledge aseptic fill finish and or biotechnology processes
• Bio-process manufacturing experience is desirable.
• Demonstrated performance in building and managing multiple multi-functional teams.
• In-depth understanding of large scale biotechnology unit operations, principles of biochemical engineering, and process data analysis.
• Experience of working in a GMP environment and working to a Quality System ensuring that oversight is provided in relation to project changes, that they are tracked, managed and implemented correctly ensuring alignment with any relevant regulatory requirements
• Proven leadership capabilities in a prior role.
• Previous experience, and knowledge, of the use of BIM models to harness schedule, cost, construction and quality drivers on a project would be very desirable.
• Working knowledge of C&Q documentation required for cGMP process equipment.
• Ability to understand and communicate risks and to develop risk mitigation strategies within a risk management process.
• Ability to create, coordinate and maintain a project plan and rapidly respond to changes in strategy and project scope.
• Understand financial and resource planning systems and processes having the ability to coordinate project level budget/resource estimates and manage actuals vs plan.