Hobson Prior is actively seeking a Commissioning Qualification Engineer (C&Q) for the esteemed RCMF project located in Cork. This role is part of a cutting-edge Worldwide Research, Development, and Medical (WRDM) facility. The RCMF project is a flagship initiative aiming at construction, commissioning, and verification for the manufacture, storage, and testing of both clinical and commercial Active Pharmaceutical Ingredient (API) products. This is a minimum 5-month contract, with the possibility of reassessment in March next year.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Operate in alignment with SOPs developed for the RCMF Project C&Q strategy and maintain GEP/cGMP compliance.
• Deliver or facilitate the development of complete C&Q documentation in accordance with quality standards and cGMP prerequisites.
• Engage in construction system mechanical completion walkdowns.
• Support with calibration verifications, both pre and post study.
• Execute C&Q field testing incorporating a comprehensive shakedown of Delta V software.
• Address and rectify deviations/non-conformances effectively.
• Collaborate closely with various stakeholders including Engineering C&Q, Engineering Project Management, Automation, and Quality to set priorities and outline verification requirements.
• Attend regular meetings to report on progress and set up additional meetings as needed.
• Adapt to the immediate needs and demands of the project.
• Collaborate with project personnel to ensure project success.

Requirements:

• A Bachelor of Science (BS) Degree in Engineering or Related Discipline from a recognized institution.
• At least 5 years of experience in API Process Equipment C&Q / Delta V Unit Operations / Shakedown testing.
• Strong communication skills with a knack for both oral and written presentations.
• Prior experience in an HPRA/FDA-regulated manufacturing setting. A robust understanding of cGMP and facility/equipment validation is essential.
• Proficiency in crafting clear, concise, and convincing professional documents.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.