Clean Utilities Engineer

2022-06-21 11:25:272050-02-11Team Horizon
Job TypeContractor
Start Date
AdvertiserHilda Lynn
Job Ref#1002530
Job Views190
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:
  • Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • This is an opportunity to work on a brand new facility working with state of the art equipment.
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
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.
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