Join a leading multinational in Cork and embark on an exciting opportunity with an award-winning biopharmaceutical organization.
Duties
* Coordinate and supervise all Commissioning and Qualification activities.
* Develop overall project strategy through C&Q planning documents.
* Create master lists of C&Q test documents and activities.
* Generate comprehensive C&Q summary reports.
* Maintain the C&Q schedule and ensure its timely completion.
* Prepare various C&Q test documents, including FAT/SAT/IV/FT/C&Qsr.
* Manage daily C&Q coordination meetings to track progress and address issues.
* Oversee the tracking and reporting of C&Q status, risks, and issues.
* Ensure safe and coordinated startup of equipment and utilities.
* Contribute to the development of User Requirement Specifications (URS) and Quality Management plans.
Education and 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.
* Preferred experience with sterile/biotech equipment within the pharmaceutical industry.
* Familiarity with safety, GMP, and environmental regulatory requirements.