Commissioning and Qualification Engineer
We are 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 company that excels in its industry.
Duties:
1. Coordinates and supervises all C&Q activities.
2. Generates C&Q planning documents detailing overall strategy for the project.
3. Develops the master list of C&Q test documents and activities.
4. Generates all C&Q summary reports.
5. Ensures the C&Q schedule is developed and maintained.
6. Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr).
7. Manages daily C&Q coordination meetings.
8. Responsible for overall tracking and reporting of C&Q status and risks/issues.
9. Ensures startup of equipment/utilities is completed in a safe and coordinated manner.
10. Assists in the development of User Requirement Specifications (URS's) and Quality.
Education & Experience:
1. 6+ years experience in Engineering or Commissioning and Qualification Management.
2. Technical qualification at third level or equivalent in Engineering.
3. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
4. Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
5. Knowledge of safety, GMP and environmental regulatory requirements.