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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 manufacturing areas related to the process and equipment, focusing on techniques, procedures, equipment, and controls.
* Address technical problems in a highly regulated Biologics Plant.
* Develop and implement improvements to equipment performance and product quality.
* Ensure compliance with policies related to Personnel, Quality, Engineering, Safety, and Finance.
* Take ownership of clean utilities (Purified Water, Water for Injection, Clean Steam, Compressed Air, Nitrogen) and work as part of a team following safety, regulatory, and organizational standards.
* Serve as SME in clean utility design, review process flow diagrams, specifications, and P&IDs, and approve them.
* Be knowledgeable in mechanical, electrical, and pneumatic utility systems and familiar with Irish, European, and international codes and standards.
* Lead safety programs and ensure safety, performance, and quality objectives are met.
* Support installation, integration, and vendor supervision of clean utility equipment.
* Develop and update procedures for clean utilities.
* Review and execute commissioning, qualification, and validation protocols.
* Lead clean utility projects and validation activities throughout their lifecycle.
* Investigate process deviations and equipment issues.
* Coordinate with engineering and maintenance teams for equipment troubleshooting, installation, and commissioning.
* Assist production in maintaining utility equipment.
* Represent the clean utility area during regulatory inspections.
* Collaborate with QC Micro, Operations, QA, and Engineering teams.
* Follow EHS policies, report incidents, and promote a safety culture.
* Participate in EHS training and medical surveillance programs.
* Perform other duties as assigned.
What you need to apply:
* A relevant third-level qualification in engineering, science, or a technical discipline (Degree or Masters preferred).
* Minimum five years' experience in Clean Utility/Equipment or Manufacturing Engineering within the pharmaceutical or healthcare industry.
* At least three years' experience in a biotechnology, pharmaceutical, or healthcare manufacturing environment.
* Experience with biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, lyophilization, sterilization processes.
* Essential experience in clean utilities.
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