Reporting to the Suite Team Lead, this role is specifically
responsible for assisting the lead in the cost, schedule and technical
aspects of the Suite scope.
Responsibilities:
* 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&#**Apply on the website**; 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.
Qualifications & Experience:
* Bachelor of Engineering or Science Degree in Engineering or
Technology related discipline.
* Minimum of **Apply on the website** years&#**Apply on the website**;
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.
* 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 Pharmaceutical
Reporting to the Suite Team Lead, this role is specifically
responsible for assisting the lead in the cost, schedule and technical
aspects of the Suite scope.
Responsibilities:
* 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&#**Apply on the website**; 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.
Qualifications & Experience:
* Bachelor of Engineering or Science Degree in Engineering or
Technology related discipline.
* Minimum of **Apply on the website** years&#**Apply on the website**;
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.
* 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
We need : English (Good)
Type: Permanent
Payment:
Category: Others
