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Clean Utilities Engineer, Sligo



Sligo, Ireland 

Job Category:

Biotech/Pharma, Engineering, Science

EU work permit required:


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Job Description:

Team Horizon currently has an exciting opening for a Clean Utilities Engineer to work on our client’s manufacturing facility.

As the Clean Utilities Engineer you will take ownership for utilities systems including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution across an advanced biologics site.

Why you should apply:

  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
  • The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
  • Excellent career progression opportunities.

What you will be doing:

  • Clean Utility Engineering Subject Matter Expert for 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 programs.
  • 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.
  • Liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/commissioning equipment.
  • Support the production team ensuring that utility equipment is maintained to ensure production schedules run efficiently.
  • 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.

What you need to apply:

  • A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
  • At least six (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 continuous 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.
  • Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
  • Ability to influence, clearly articulate expectations and communicate with key stake holders, team members and contractors.
  • Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
  • Total commitment to quality and a high standard of work always.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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