19903 – Clean Utilities Engineer – Carlow Contractor

Purpose

Reporting into Engineering Lead the Clean utilities Engineer will take ownership for the clean utilities (such as, but not limited to, Water for injection, clean steam, clean dry air, nitrogen). Responsible for the clean utilities’ equipment.

Responsibilities

• 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. The Clean Utility engineer role shall be responsible for execution of the Utility PQ’s with the required support from site resources.
• 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.

• 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 company 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 programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs.
• 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.

Requirements

• Degree qualification or equivalent (Science, Engineering, Technical).
• Experience in aseptic manufacturing.
• 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