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 exe. cution, 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!
