Commissioning and Qualification Engineer
We're currently recruiting for an exciting opportunity with a leading multinational biopharmaceutical organization based in Cork. This is an excellent position for anyone who wants to join a top company in their field.
Duties:
* Coordinate and supervise all C&Q activities.
* Create C&Q planning documents outlining the overall strategy for the project.
* Develop the master list of C&Q test documents and activities.
* Generate all C&Q summary reports.
* E nsure the C&Q schedule is developed and maintained.
* Generate all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr).
* Manage daily C&Q coordination meetings.
* Oversee the overall tracking and reporting of C&Q status and risks/issues.
* Ensure the safe and coordinated startup of equipment/utilities.
* Assist in developing User Requirement Specifications (URS's) and Quality documentation.
Education & Experience:
* 6+ years of 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.
* Experience working with sterile / biotech equipment within the pharmaceutical industry is preferred.
* Knowledge of safety, GMP, and environmental regulatory requirements.