Project Manager for a large scale Fill Finish Project in the Pharmaceutical Industry. Management of the capital project against Safety, Cost, Quality and Schedule commitments, delivering the Capital Project as part of a strategic program.
The Project Manager within the Site Capital Projects group and is responsible for the scoping and execution of projects supporting Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Component Preparation and Packaging areas.
* Management of the capital project against Safety, Cost, Schedule and Quality.
* Ensure the delivery of project through the Capital Project Management Process.
* Development, reporting and management of the project Capital Budget.
* Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
* Project input will span from concept, through design and on to construction, commissioning and operation.
* Provide direct leadership and technical guidance on the project to ensure cost effective options and contracting strategies are pursued.
* Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
* Manage third party contractors and outsourced partners to ensure the optimal delivery of the project against safety, cost, quality and schedule objectives.
* Drive a safety culture through the project team and ensure that the project is in compliance with site and corporate regulatory authority guidelines.
* Optimise the use of resources to leverage SME knowledge, collaborating across the Network team to minimize project cost and complexity.
* Manage the project cash flow and capital budget.
* Lead engagement of staff in a dynamic business environment.
* Working with various stakeholders, to scope the project and ensure the requirements are satisfied.
* Development and management of change controls.
* Participate as a member of multidisciplinary site and multisite teams.
* Development of detailed specifications, engineering documents, protocols and standard operating procedures.
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Education / Experience:
* Extensive experience of directly leading (€50MM+) Capital Projects.
* Technical qualification at third level or equivalent in Engineering.
* Experience of working in an Architectural & Engineering (A&E) on Biopharmaceutical projects.
* Typically 8+ years engineering experience, preferably in the biotechnology/bio-processing industry.
* Demonstrated experience in a GDP Compliant environment.
* Knowledge of safety, GMP and environmental regulatory requirements.
* Proven ability around working cross functionally, delivering technical solutions and identifying improvements.
* Solid leadership, technical writing, and communication/presentation skills .
* Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
* Travel at various times may be required to support execution of projects.
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