Career Category

Job Description

01-Jun-21

Senior Project Manager – Fill Finish Facility.

Amgen Dun Laoghaire - Dublin

Role Overview:

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.

Summary:

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.

Key Responsibilities:

• 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 AMGENs 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.