Maintenance and Utilities Engineer - GMP Manufacturing

About the Role

Our client, an established regulated manufacturing company based in County Kerry, Ireland, is seeking a Maintenance and Utilities Engineer to join their team. Reporting to the QA Lead for Production and Maintenance, the engineer will be responsible for supporting maintenance, calibration, validation, and ongoing improvement of manufacturing equipment, instrumentation, and site systems.

Key Responsibilities

• Oversee and support maintenance activities for all manufacturing equipment and instrumentation on site, ensuring preventive maintenance schedules are adhered to.
• Maintain accurate documentation and records for maintenance, calibration, and equipment performance.
• Assist troubleshooting and technical problem solving across manufacturing equipment and utilities such as purified water, WFI, HVAC, and autoclaves.
• Coordinate with external contractors and service providers for equipment maintenance, calibration, qualifications, and repair tasks.
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes for new and existing equipment, including validation documentation.
• Manage and update validation, calibration, and maintenance records aligned with the site Master Validation Plan.
• Support purchasing and procurement of spare parts, consumables, and engineering materials.
• Collaborate with Production and Quality teams to minimize equipment downtime and maintain manufacturing continuity.
• Identify and recommend improvements to equipment, processes, and site systems as part of continuous improvement initiatives.
• Ensure all engineering activities comply with site procedures and applicable regulatory requirements like GMP/cGMP.
• Assist with audits and inspections, liaising with regulatory bodies when required.

Qualifications and Experience

• Technical qualification in Engineering, Maintenance, Mechanical, Electrical, Instrumentation, Manufacturing, or related disciplines.
• Proven experience in manufacturing or regulated production environments, particularly in maintenance, utilities, or engineering fields.
• Experience with maintenance and calibration of manufacturing equipment and instrumentation.
• Familiarity with planned preventative maintenance programs and maintenance documentation.
• Knowledge of utilities including purified water, Water for Injection (WFI), HVAC, and autoclaves is advantageous.
• Experience with IQ, OQ, PQ, validation, calibration, or qualification activities beneficial.
• Understanding of GMP or cGMP regulatory frameworks preferred.
• Strong skills in contractor management, documentation, record keeping, and technical reporting.
• Practical approach with strong troubleshooting, communication, organization, and time management skills.
• Ability to work effectively across Quality, Production, and Management teams.

What We Offer

• Opportunity to work within a well-established and highly regulated manufacturing environment.
• A diverse engineering role involving maintenance, calibration, validation, and utilities support.
• Hands-on exposure to manufacturing equipment, instrumentation, and critical site utility systems.
• Close collaboration with Quality, Production, and external technical experts.
• Long-term career development prospects in the engineering field.
• Supportive and collaborative team atmosphere with multi-departmental interaction.
• Immediate interview opportunities available for qualified applicants.