Black Utilities Suite Lead
Reporting to the Carlow 2 project manager, as part of a multi-discipline team, specifically responsible for the delivery to CQ of the black utility scope for a multi-product aseptic filling facility. This candidate will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA.
- Reporting to Carlow 2 Project Manager.
- Define and agree, with other Suite team leads and the Project Manager, the physical and procedural scope and scope boundaries.
- Develop, within the overall project schedule, a schedule for the delivery of all aspects of the black utilities for the project.
- Issue a project charter for the Suite project execution within the overall capital project.
- Administer and report on the Black Utilities Suite Budget within the overall project budget structures.
Lead and manage scope, budget, schedule, safety, quality and personnel of the suite team.
- Develop, document, agree and implement an execution strategy to deliver the scope in a 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 black utility systems.
- Facilitate project job specification processes with A/E and end user.
- Develop or contribute to the pertinent Mechanical/HVAC/Utility narratives for the project Design Manual and subsequent Design Reports.
- Coordinate review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Job Specifications, and PO’s/Data Sheets.
- Coordinate, along with procurement, vendor qualification/selection for major equipment and packaged equipment.
- Assure that project utilities designs are safe, constructible, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
- Participate in Value Engineering.
- Attend FATs when appropriate.
- Review C&Q plans/protocols as related to utilities systems.
- Provide appropriate expertise during C&Q activities as needed.
- Participates to the supplier’s selection.
- Helps define the C&Q strategy.
- Coordinates C&Q start-up activities , punch list follow-up.
- Liaise with the various stakeholders on the overall project to ensure clear communication between all parties.
- Co-ordinate and facilitate, with the contract engineering firm, the GMP design reviews.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
- Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
- Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
- Lead and attend daily communication meetings, as appropriate, with suite teams and report progress.
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
- Safety of all suite team members for the duration of the design, construct, commission validate and handover of the suite scope.
- Clear, and documented, definition of scope and scope boundaries
- Delivery of the agreed milestones on the schedule within budget constraints.
- Delivery of stakeholder agreed scope for clean utilities to Commissioning Qualification.
Qualifications & Experience:
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 8-10 years’ experience similar role in Clean Facilities/Utilities systems within Pharmaceutical industry.
- Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- The candidate will be a convincing communicator with strong interpersonal skills
- Experience of design and or construction/handover of Black Utilities for pharmaceutical facilities.
- Ability to work in design and construction large project environment within Ireland.
- Strong interpersonal and communication skills (verbal/written)
- Working knowledge of process control systems and automation. DeltaV, BMS experience beneficial.
- 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, and PCs.
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