14787 – Project Manager -Carlow Contractor

Purpose

This is a 11 month contract

Reporting to the Project Manager, as 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.
This candidate will be required to work closely with Suite Team Leads in the management of multiple cross-functional Suite teams and to coordinate activities between the Suite, Design, Construction, Process, Technical Operations, C&Q, IPT and QA teams.

Responsibilities:

• Reporting to the Project Manager.
• Define and agree, with Suite Team Leads and the Project Manager, the physical and procedural scope and scope boundaries, within the Carlow operating facility footprint.
• Lead the development of project plans and successfully execute them according to the established safety, schedule, cost and performance standards.
• 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 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 (Integrator) 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 (Integrator), Site Contractors (Trade Partners) and strategic vendors 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 the coordinated development of construction, procurement, C&Q and project control strategies, into plans for the execution of the project.
• Participate in Value Engineering.
• Lead and attend daily communication meetings, as appropriate, with suite teams and report progress.
• Maintain a project wide clean and safe working environment by enforcing procedures, policies, and regulations.
• Safety of all project team members for the duration of the design, construction, commissioning validation and handover of the suite scopes.
• 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.

Minimum Qualifications and Experience: 

• 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
• A working knowledge of FDA and EU regulations is preferred.
• The candidate will be a convincing communicator with strong interpersonal skills
• In-depth understanding of large-scale biotechnology unit operations, principles of biochemical engineering, and process data analysis.
• Strives for results and sets ambitious tangible and measurable targets; takes personal responsibility for achieving results; reviews and evaluates team progress against agreed targets, timelines and budgets.
• 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.
• Ability to create a productive and supportive team environment and to resolve, or manage, conflicts and disputes.
• Ability to engage and align other stakeholders outside the project team.
• Working knowledge of C&Q documentation required for cGMP process equipment.
• Fluent in English, written and verbal.
• Ability to generate and communicate project plans and schedules.
• Working knowledge of word processing, spreadsheets, database management software, CAD software, schedule management software (P6), and PCs.
• Working knowledge of process control systems and automation. Delta, BMS experience beneficial.
• Experience in the operation of large-scale biotechnology processes is desirable.
• Bio-process manufacturing experience is desirable.