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Senior Biotech CQV Engineer
3 weeks ago
Biotech CQV Engineer - Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site based
Pay: €55 - 65 per hour
Experience: 8+ 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 get experience into Ireland's leading aseptic manufacturing plant.
Owns projects, equipment, responsible for document drafting and protocol execution
Completing all qualification training and getting up to speed with SOPs.
A buddy will be assigned to provide support during the onboarding process
Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects.
Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation
Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report
Generating, reviewing, and executing documents for both company and vendors.
Collaborating closely with system owners, QA and other stakeholders.
Provide technical assistance during investigations and system design.
Coordinates and Supervises all C&Q activities on their systems.
Ensures the C&Q schedule is maintained.
Manages Daily C&Q coordination meetings.
Responsible for Tracking and Reporting of C&Q status and risks/issues.
Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Requirements
6+ years experience in Engineering or Commissioning and Qualification Management
Technical qualification at third level or equivalent in Engineering.
Extensive knowledge and demonstrated experience managing Commissioning and
Qualification for Pharmaceutical / Biotechnology projects preferred
Knowledge of safety, GMP and environmental regulatory requirements.
Demonstrated strong Communication and Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry
Familiarity with paperless validation systems.
Experience in commissioning and qualification of process equipment and or Utilities, both would be a preference.
Experience in vendor documentation and execution, both onsite at factories and at vendor sites.
Experience in the entire commissioning and qualification process, from URS to QSR (Qualification Summary Reports).
Experience with Deviation/Discrepancies.
The candidate should be capable of managing multiple different projects simultaneously
Package
Contract role - Hourly rate €55 - €65 per hour
Minimum 12 month contract with the possibility of an extension.
At least three days per week is the onsite expectation
