Job Title: Commissioning and Qualification Engineer
Description:
We are seeking a highly skilled Commissioning and Qualification Engineer to join our team at an award-winning biopharmaceutical organization based in Cork.
Duties:
* Coordinates and supervises all C&Q activities, ensuring seamless project execution.
* Develops comprehensive C&Q planning documents outlining overall strategy for each project.
* Create master lists of C&Q test documents and activities, facilitating efficient project management.
* Generate detailed C&Q summary reports to track progress and identify areas for improvement.
* Maintain accurate C&Q schedules, ensuring timely completion of projects.
* Produce all C&Q test documents, including C&Q Plans, Set to Works, FAT, SAT, IV, FT, and C&Qsr, as required.
* Lead daily C&Q coordination meetings to discuss project status and address any risks or issues that arise.
* Oversee the tracking and reporting of C&Q status, highlighting potential risks and mitigation strategies.
* Evaluate the startup of equipment and utilities to ensure safe and coordinated commissioning.
* Collaborate with cross-functional teams to develop User Requirement Specifications (URS's) and Quality procedures.
Requirements:
* A minimum of 6 years of experience in Engineering or Commissioning and Qualification Management.
* A technical qualification at third level or equivalent in Engineering.
* Extensive knowledge and demonstrated expertise in managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
* Prior experience with sterile/biotech equipment within the pharmaceutical industry is preferred.
* Strong understanding of safety, GMP, and environmental regulatory requirements.