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Clean Utilities Commissioning and Qualification Engineer, Dun Laoghaire-Rathdown
Client:
JobContax
Location:
Dun Laoghaire, Dublin
Job Category:
Other
EU work permit required:
Yes
Job Reference:
5941b70b7cc0
Job Views:
78
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Clean Utilities Commissioning and Qualification Engineer - Dun Laoghaire, Dublin
Employment Type: Contract
Experience: 6+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.
Responsibilities:
1. Own projects and equipment; responsible for document drafting and protocol execution.
2. Act as Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects.
3. Ensure C&Q activities are completed safely, per schedule, and in compliance with GMP and Quality Requirements.
4. Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation.
5. Generate all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report).
6. Provide technical assistance during investigations and system design.
7. Coordinate and supervise all C&Q activities on assigned systems.
8. Maintain the C&Q schedule.
9. Manage daily C&Q coordination meetings.
10. Track and report C&Q status and risks/issues.
11. Ensure the startup of equipment/utilities is completed safely and in a coordinated manner.
12. Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Requirements:
1. 6+ years experience in Engineering or Commissioning and Qualification Management.
2. Technical qualification at third level or equivalent in Engineering.
3. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical/Biotechnology projects preferred.
4. Knowledge of safety, GMP, and environmental regulatory requirements.
5. Demonstrated strong communication and leadership skills.
6. Ability to collaborate with senior stakeholders to achieve optimal outcomes.
7. Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry.
8. Familiarity with paperless validation systems.
Package:
Minimum 12-month contract with the possibility of an extension.
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