A utilities engineer is required for a multinational pharmaceutical client at their facility in Cork. This is a full-time, on-site, permanent position that involves managing the operations of filling, packaging lines, autoclaves, compounding equipment, clean utilities, HVAC, water system, and gas distribution lines.
The utilities engineer plays a vital role in ensuring routine compliance to relevant SOPs and coordinates with other departments and vendors. Key responsibilities include:
* Managing vendor selection and ensuring service quality, reviewing method statements and risk assessments, and obtaining work permits before starting activities.
* Coordinating with manufacturing, site QA, and participating in MRBs and audits if required.
* Ensuring the selection and usage of proper PPE for respective areas and adhering to all company & legislative EHS requirements. Supporting and implementing all Global EHS programs and initiatives.
* Participating in preparation, execution, and review of qualification and engineering tests/protocols (URS, DQ, FAT, IQ, OQ, PQ)
* Ensuring checks are carried out as per scheduled for respective areas and reviewing records for building maintenance activities.
* Ensuring proper procedures for disposal of waste and hazardous material.
* Working closely with QA team for initiating change controls, impact assessment, deviation management, and CAPA closure.
Requirements:
* A minimum of a BEng degree with a minimum of five years' experience in an engineering role preferably within the pharmaceutical industry.
* Must have experience of working in a highly regulated cGMP environment.
* Experience of FDA, HPRA audits an advantage.