Commissioning and Qualification Engineer
This is an exciting opportunity with a leading multinational biopharmaceutical organization based in Cork.
Duties
* Coordinates and supervises all C&Q activities, ensuring smooth project execution.
* Develops comprehensive C&Q planning documents outlining the overall project strategy.
* Creates master lists of C&Q test documents and activities to facilitate efficient project management.
* Generates regular C&Q summary reports to stakeholders, highlighting progress and any issues that may arise.
* Ensures the C&Q schedule is developed and maintained, aligning with project timelines.
* Prepares and generates various C&Q test documents, including plans, sets to work, FATs, SATs, IVs, FTs, and C&Q SRs.
* Manages daily C&Q coordination meetings to ensure seamless communication among team members.
* Oversees the tracking and reporting of C&Q status and risks/issues, providing timely updates to stakeholders.
* Facilitates the safe and coordinated startup of equipment and utilities, minimizing downtime and ensuring compliance with regulatory requirements.
* Assists in developing User Requirement Specifications (URS) and Quality documents to support project deliverables.
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 highly desirable.
* Thorough understanding of safety, GMP, and environmental regulatory requirements.