Job Reference: JO-2006-65250_1592499537
The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management, and Inclusion. Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify, analyze and prioritize technical or business-related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes, systems, and behaviors. Contribute to a data-driven decision-making process, Ensure effective application of LeanSixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners. Minimal work direction needed, highly skilled and knowledgeable to the position.
- 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 teams 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 MSD Manufacturing Network as required to support projects.
- 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
- 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 the 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 the 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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