Clean Utilities Engineer
Team Horizon is seeking a Clean Utilities Engineer for a leading manufacturing company in Sligo.
Why you should apply:
* You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.
* Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
* Provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls.
* The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant.
* This position requires developing and implementing changes that will improve equipment performance and consequently product quality.
* To ensure continual compliance with the policies relating to Personnel, Quality, Engineering, Safety and Finance.
* The Clean Utilities Engineer will take ownership for clean utilities (Purified Water, Water for Injection, Clean Steam, High Quality Compressed Air and Nitrogen Distribution) and to work as a team member in line with all safety, regulatory and organizational requirements.
* Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.
* Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
* SME in mechanical, electrical and pneumatic utility systems.
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.
* Delivery of safety, performance and quality goals.
* Support clean utility equipment installation, integration and coordinate vendor supervision as required.
* Develop and modify procedures as needed to support the clean utility area.
* Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements.
* Participate and lead clean utility project implementations.
* Leadership of clean utility and validation activities during project life cycle.
* Investigate process exceptions or equipment malfunction incidents affecting the process.
* To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
* Support the Production Team in ensuring that utility equipment is maintained to meet requirements.
* Present on clean utility area in regulatory inspections ensuring successful outcomes.
* Cross functional collaboration with QC Micro, Operations, QA and Engineering.
* Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
* Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
* Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
* Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
* Attend all required EHS training and medical surveillance programs.
* All other duties as requested or assigned.
What you need to apply:
* A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
* At least five years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
* At least three years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
* Experience in clean utilities is essential.
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