Commissioning and Qualification Engineer
We are currently recruiting for a highly skilled Commissioning and Qualification (C&Q) Engineer to join our award-winning biopharmaceutical organization based in Cork.
This is an excellent opportunity for individuals seeking to work with a leading multinational company recognized for its expertise.
Duties:
* Coordinate and supervise all C&Q activities.
* Develop C&Q planning documents outlining the overall strategy for the project.
* Create the master list of C&Q test documents and activities.
* Generate comprehensive C&Q summary reports.
* Maintain the C&Q schedule and ensure its development.
* Prepare all C&Q test documents, including FAT/SAT/IV/FT/C&Qsr.
* Manage daily C&Q coordination meetings.
* Oversee the tracking and reporting of C&Q status and risks/issues.
* Ensure the safe and coordinated startup of equipment and utilities.
* Collaborate in the development of User Requirement Specifications (URS's) and Quality.
Requirements:
* 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.
* Knowledge of safety, GMP, and environmental regulatory requirements.
Key Skills:
* Strong organizational and leadership skills.
* Ability to manage multiple priorities and deadlines.
* Excellent communication and problem-solving skills.