Senior CQV Engineer (BBBH28100) Dublin South, Republic of Ireland
LSC have a great contract opportunity for a Senior C&Q Engineer to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* 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)
* Coordinates and Supervises all C&Q activities on their systems.
* Responsible for Tracking and Reporting of C&Q status and risks/issues.
* Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
* 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.
* Collaborating closely with system owners, QA and other stakeholders.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Sarah Ninan at +353 214777329 if you have any more questions about this opportunity!
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