Commissioning and Qualification Engineer
We are seeking a skilled Commissioning and Qualification Engineer to join our team at Lifescience, an award-winning biopharmaceutical organization based in Cork.
This is an excellent opportunity for anyone who wants to work with a leading multinational company that sets the standard in their field.
Duties:
1. Coordinate and supervise all C&Q activities.
2. Generate C&Q planning documents detailing overall strategy for the project.
3. Develop the master list of C&Q test documents and activities.
4. Generate all C&Q summary reports.
5. Ensure the C&Q schedule is developed and maintained.
6. Generate all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr).
7. Manage daily C&Q coordination meetings.
8. Track and report on C&Q status and risks/issues.
9. Ensure safe and coordinated startup of equipment/utilities.
10. Assist in developing User Requirement Specifications (URS's) and Quality.
Requirements:
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 experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
4. Experience with sterile/biotech equipment within the pharmaceutical industry is preferred.
5. Knowledge of safety, GMP and environmental regulatory requirements.