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Clean Utilities Engineer

Reference:A007323 Location: Carlow
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer

The Clean Utilities Engineer will perform an integral role in the development of the company.
You will take ownership for the clean utilities (such as, but not limited to, Water for injection, clean steam, clean dry air, nitrogen) and the clean utilities equipment.
You will provide leadership, cross functional support and technical expertise to IUFT, maintenance and manage their operation through design, construction, validation, start-up and commercial manufacturing. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to their customers.
As the clean utilities engineer, you will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable standards for Quality and EHS compliance, high standards of quality and meets all regulatory requirements as well as ensuring that all equipment is adequately qualified.

You will be responsible for:

  • Delivery of schedule milestones throughout the project duration.
  • Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones
  • Driving operational and technical excellence to deliver all components of a stable clean equipment portfolio supporting PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment.
  • Assist in the design and operationalisation of a successful clean utilities team that delivers right-first-time utilities to achieve production requirements.
  • Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
  • Comply with the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
  • Ensure that the clean utilities team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role.
  • Develop and maintain training programmes.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various clean utility systems; ensure all work is subsequently carried out in line with same.
  • Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start.
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.

Expected Travel: 20%
Reporting to: Quality Lead

What you have:

  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience with facility commissioning and start-up an advantage.
  • A strong career history in pharma (ideally working with clean utilities) and familiarity with a highly regulated environment.
  • Evidence of continuous professional development is desirable.
  • Lean Six Sigma Methodology experience desired
  • Delivery of safety, performance and quality goals.

What you need:

  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Experience in aseptic manufacturing
  • Demonstrated leadership with at least 5 years’ experience in a people management role.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • SME (subject matter expert) in clean utility engineering lifecycle (design, through to sustaining operations; including ARM – asset reliability maintenance).
  • SME in mechanical, electrical and pneumatic utility systems
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job-related computer applications required
  • Demonstrated site operations project experience, from capital project to continuous support to manufacturing operations.
  • Proven track-record in delivering results in a world-class supply organisation.
  • Experience of working in a cross functional environment.

Your personality:

  • Positive, flexible action-oriented attitude.
  • Energetic and enthusiastic, as the clean utilities engineer, you will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
  • The passion to expand the future of Carlow.
  • Ability to participate in and lead highly effective teams.
  • The desire to continuously learn, improve and develop.
  • A great communicator, decisive decision-maker with a proven ability to deliver excellence
  • Strong leadership and interpersonal skills.
  • Willingness to support the team and a strong focus on delivering excellence.
  • A passion for coaching others by sharing your skill set and expertise.
  • High personal integrity, credibility, energy and flexibility.
  • Model our leadership behaviours and use the MPS principles to achieve project success.
  • Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.

The company you will work for:

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.