Clean Utilities Engineer
We are seeking a Clean Utilities Engineer to join our team at an award-winning Pharmaceutical organization in Carlow.
Duties:
* 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 SAT, IC, OC, IQ, OQ, PQ 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.
* Ownership of the clean utility Quality risk assessments and close out.
* 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.
* Act as Owner rep for Turnover, SAT and OQ execution for all clean utilities.
* 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.
Experience and Education:
* Degree qualification or equivalent (Science, Engineering, Technical).
* Experience in CQV execution.
* Knowledge and previous experience of Utility start up and qualification.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.