Site Engineer – Pharmaceutical Manufacturing

About the role

The Site Engineer will support a leading pharmaceutical manufacturing site in Kerry, ensuring that all equipment and systems are maintained, calibrated, and validated to the highest standards. Reporting to the QA Lead for Production and Maintenance, you will play a key part in keeping the plant compliant with regulatory requirements.

Key responsibilities

• Monitor and control maintenance and calibration of all manufacturing equipment and instrumentation.
• Liaise with external subcontractors for equipment maintenance, calibrations, and qualifications.
• Assist with validation, calibration, and maintenance of Purified Water, WFI, HVAC systems, and autoclaves.
• Oversee the engineering function, ensuring the preventive‑maintenance schedule and Master Validation Plan are followed and records are up‑to‑date.
• Purchase and procure spare parts and consumables as needed.
• Support IQ, OQ, and PQ activities for new and existing equipment.
• Collaborate with the Qualified Person (QP) on continuous‑improvement initiatives.
• Interact with regulatory bodies such as HPRA and FDA.

Required profile

• 3‑5 years of experience in a similar site‑engineer role within a regulated manufacturing environment.
• Bachelor’s degree in Engineering or a related discipline.

Required skills

• Equipment maintenance and calibration
• Validation activities (IQ, OQ, PQ)
• Purified Water and WFI system knowledge
• HVAC system expertise
• Autoclave operation and maintenance
• Preventive‑maintenance scheduling
• Procurement of spare parts and consumables
• Regulatory compliance (HPRA, FDA)