13409 – Process Project Engineer – Carlow Contractor

Purpose: 

Reporting to the Suite Team Lead, as part of a multi-discipline team, specifically responsible for assisting the lead in the cost, schedule and technical aspects of the Suite scope. 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. Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.

Responsibilities:

• Reporting to Suite Team Lead.
• Assist in the development and delivery, within the overall project schedule, of a schedule for the delivery of all aspects of the Suite scope.
• Provide support for the administration, within a project charter, of the Suite project execution within the overall capital project budget and schedule.
• 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.
• Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
• Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
• Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
• Assist in the assurance that project utilities designs are safe, constructible, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
• Support GES Suite Leads and C&Q team to coordinate preparation and lead FATs/C&Q field execution.
• Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
• Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
• Provide coordination expertise during C&Q activities as needed.
• Assist in the coordinating of 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.
• Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
• Coordinate third party vendors during SAT execution. Review and contribute to SAT protocols.
• 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.
• Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company
• Manufacturing Network as required to support Project.
• Delivery of the agreed milestones on the schedule within budget constraints.
• Delivery of stakeholder agreed scope for Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.
• The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (Cork). Flexibility is required in this regard.

Minimum Qualifications and Experience:

• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
• Minimum of 4-6 years’ experience similar role in Pharmaceutical Facility/ Building/Utilities systems within Pharmaceutical industry.
• Working knowledge of standards as they apply in biotechnology processes industries 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 construction/handover of pharmaceutical process and building facilities 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 control systems and automation.
• Working knowledge of C&Q documentation required for cGMP project delivery.
• 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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