Clean Utilities Engineer BIOPHARMA
My Client is an award winning US biopharma multinational and they are expanding their operations to introduce a state of the art biologics facility in Sligo. It is a very exciting time to be joining, they are currently in growth phase and have invested heavily into this site.
As part of this biologics startup facility, they are now recruiting an experienced Clean Utilities Engineer to join their expanding Engineering Teams. You will be responsible for the utilities systems including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution across this advanced biologics site.
- Permanent position with excellent salary and full benefits package.
- Excellent career development opportunities with this company!
- Flexitime available for a healthy work, life, balance!
There are genuinely a great company to work for and have a very low turn over of staff. Even though they are a major multinational and household name, the site has a lovely ''family feel''. Cultural fit for them is so important. They encourage ''outside the box'' thinking with new ideas always welcome. They also promote internally where at all possible. This client really does look after their staff and have consistently won various awards year on year which reflect this and their vision.
The successful candidate will be degree qualified with minimum 5 years' clean utilities engineering experience within the Biopharma/Pharmaceutical Industry, an excellent communicator and influencer with proven problem solving skills and a passion for making a difference in people lives.
- Leadership of clean utility and validation activities during project life cycle.
- Clean Utility Engineering Subject Matter Expert for from design phase to equipment handover.
- SME in mechanical, electrical and pneumatic utility systems.
- Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID's.
- 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.
- 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
You will have…
- Relevant Degree qualification in engineering, scientific or technical discipline.
- Minimum of 5 years experience in a similar role within a Pharma/Biopharma manufacturing environment
- Experience in clean utilities/equipment within Pharma/Biopharma is essential (including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution)
- Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
- 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.
- Excellent communication and problem solving skills
If you are excited at the prospect of progressing your career to the next level and being part of an exciting biologics start-up in Sligo, then I would love to speak with you!
For more information and to review the full job spec and scope of this exciting opportunity, please click apply to the position. I would be delighted to speak with you and guide you through the whole process!
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