Clean Utilities Engineer

2530 - Clean Utilities Engineer

 

Team Horizon is seeking a Clean Utilities Engineer to 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.

 

 

Why you should apply:

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  Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.


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  This is an opportunity to work on a brand new facility working with state of the art equipment.

 

What you will be doing:

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  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. 


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  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.


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  To ensure continual compliance with the policies relating to Personnel, Quality, Engineering, Safety and Finance.


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  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.


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  Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.


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  Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.


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  SME in mechanical, electrical and pneumatic utility systems


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  Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices


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  Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programmes.


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  Delivery of safety, performance and quality goals.


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  Support clean utility equipment installation, integration and co-ordinate vendor supervision as required


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  Develop and modify procedures as needed to support the clean utility area.


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  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


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  Participate and lead clean utility project implementations.


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  Leadership of clean utility and validation activities during project life cycle.


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  Investigate process exceptions or equipment malfunction incidents affecting the process.


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  To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/commissioning equipment.


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  Support the Production Team in ensuring that utility equipment is maintained to meet requirements


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  Present on clean utility area in regulatory inspections ensuring successful outcomes.


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  Any other duties as assigned. 

 

What you need to apply:

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  A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)


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  At least five (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.


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  At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.


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  Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.


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  Experience in clean utilities is essential.