Asset Recruitment Ltd

Process Project Engineer (BB-1C3B2)

Found in: Neuvoo IE

This role reports into the Suite Team Lead and is specifically responsible for assisting the Lead in the cost, schedule and technical aspects of the Suite scope. 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: * 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. * Assist in the coordinating of C&Q start-up activities , punch list follow-up. * Facilitate/expedite Mechanical Completion in conjunction with the Construction team. * 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.Requirements: * Bachelor of Engineering or Science Degree in Engineering or Technology related discipline. * Minimum of 4 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. * Experience of design and construction/handover of pharmaceutical process and building facilities for pharmaceutical facilities. * Working knowledge of control systems and automation. * Working knowledge of C&Q documentation required for cGMP project delivery. * Ability to generate and communicate project plans and schedules

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