Clean Utilities Engineer

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 co-ordinate 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, trouble shooting 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 (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.


• At least three (3) 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.