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Sean McCarthy
Life Science

+3530212339371
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Details

Commissioning and Qualification Lead - Fill Finish


Reference:SMC47569 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Engineering Manager

We’re currently recruiting for an exciting opportunity with a biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

· Coordinates and Supervises all C&Q activities
· Approves C&Q planning documents detailing overall strategy for the project.
· Develops and approves the master list of C&Q test documents and activities.
· Reviews and Approves all C&Q summary reports.
· Ensures the C&Q schedule is developed and maintained.
· Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
· Pre‐Approval and Post approval of C&Q test documents.
· Manages Daily C&Q coordination meetings.
· Responsible for Overall 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)


Education & Experience

· 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 project
· Experience of sterile / biotech equipment within the pharmaceutical industry is preferred
· Knowledge of safety, GMP and environmental regulatory requirements.
· Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.