Website Ref: TPM03968
Our client is a global biopharmaceutical company based in Meath and is looking for a Utilities Engineer to support the operation readiness plan for the start-up of the plant engineering activities. This is a key role to ensure that the activities and programs are delivered for start-up operations of the site Utilities which are clean wet utilities, lab and process gas, HVAC, temperature-controlled units, electrical services, safety engineering, black utilities are provided.
- Be responsible for adherence to site and corporate QMS for Utility Systems.
- Support audits, investigations, deviations and corrective actions for clean utility systems.
- Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
- Author, Review and approve all Utility Systems startups, change requests, and SOP’s.
- Support lead factory acceptances and site acceptance trials, FATs and SATs.
- Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.
- The primary focus of the position is on GMP and black utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems, CTU systems, Electrical systems, automation systems).
- Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
- Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.
- Support and lead the handover of targeted utility systems from the projects /build team to the sustaining operations and maintenance team.
- Provide support to the reliability team in areas such as FMECA, Criticality Assessments, Predictive instrumentation deployment.
Qualifications & Experience:
- Degree or 3rd Level Qualification (Engineering), Masters preferred.
- Must have qualification in Electrical, Mechanical or Process Engineering (Level 8 Degree).
- > 5-7 years’ experience in the Pharmaceutical industry, preferably within project delivery, CQV, Validation environment.
- Experience with FAT, SAT, Equipment walkdowns, post IQ OQ Transfer of responsibility.
- Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS & GMP).
- Ability to prepare budgets and tightly control expenditures.
- Very strong knowledge of industrial safety standards.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing or Quality etc.).
- Knowledge and experience in applying Six Sigma and Lean Methodologies.
- Demonstrated leadership and change management skills with a continuous improvement focus.
- Demonstrated understanding of Project life Cycle, from design through to commissioning/qualification & retirement.
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