Project Coordinator – Pharma

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Project Coordinator – Pharma

Our client is a global leading pharmaceutical company, seeking a Project Coordinator to join one of their sites in Ireland.

Reporting to the project manager, as part of a multi-discipline team, specifically responsible for the delivery to CQ of the project scope for an API facility.  The successful candidate will be required to work closely with a cross-functional Suite teams and coordinate activities between Design, Construction, Process, Automation, Technical Operations, C&Q, Operations and QA.

Role Functions:

·       Lead the development of, and monitoring to, project plans and successfully execute them according to the established safety, schedule, cost and performance standards.

·       Define and agree, with Suite team leads and the Project Manager, the physical and procedural scope and scope boundaries, within the project operating facility footprint.

·       Manage 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 and manage scope, budget, schedule, safety, quality and personnel discussions with the Suite Leads of the project.

·       In collaboration 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.

·       Track and report progress as required against project deliverables.

·       Foster a strong relationship between the Client Project Team, EPCM Contractor (Integrator), Site Contractors (Trade Partners) to ensure delivery of project.

·       Ensure that a strong safety culture is adopted throughout the execution of the 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 engineering and user requirements for the project Suites.

·       Facilitate the coordinated development of construction, procurement, C&Q and project control strategies into plans for the execution of the project.

·       Lead and attend daily communication meetings, as appropriate, with suite teams and report progress.

·       Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.

Responsibilities include but are not limited to:

·       Safety of all project team members for the duration of the design, construct, commission qualification and handover of the suite scope.

·       Clear, and documented, definition of scope and scope boundaries within the Suite teams.

·       Management of scope issues as they arise during the project

·       Delivery of the agreed milestones on the schedule within budget constraints.

·       Delivery of stakeholder agreed scope for project Suites to Commissioning Qualification.

Requirements:

·       A Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

·       10+ years of relevant experience in Project Management of larger projects in the Pharma industry including significant experience managing API projects.

·       A working knowledge of FDA and EU regulations is preferred.

·       Be a convincing communicator with strong interpersonal skills

·       Demonstrated performance in building and managing multiple multi-functional teams.

·       Demonstrated performance in building and managing multiple multi-functional teams.

·       Understand financial and resource planning systems and processes and have ability to coordinate project level budget/resource estimates and manage actuals vs plan.

·       Working knowledge of C&Q documentation required for cGMP process equipment.

·       Experienced 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

·       Working knowledge of process control systems and automation. DeltaV, BMS experience beneficial.