Site Engineer

palebluedotrecruitment; Munster; Presencial; EUR 50 000 - 70 000; Tempo integral

Resumo da oferta

Our client in Co. Kerry seeks a Site Engineer to support maintenance, calibration, validation and continuous improvement of manufacturing equipment and site systems. You will work with Quality, Production, external contractors and regulators to ensure compliance and reliable operation of critical utilities.

You will assist IQ/OQ/PQ activities, maintain accurate records, and drive improvements across equipment and utilities in a regulated manufacturing environment.

Qualificações

• Experience in a regulated manufacturing environment with maintenance, calibration, validation and site systems.
• Ability to liaise with quality, production, contractors and regulatory bodies to ensure compliance.
• Familiar with IQ/OQ/PQ activities and site validation plans.

Responsabilidades

• Monitor, control and support maintenance activities for all on-site equipment and instrumentation.
• Ensure planned preventative maintenance schedules are followed and records maintained.
• Assist with IQ, OQ and PQ activities and documentation for new and existing equipment.
• Oversee day-to-day engineering function to maintain site systems and utility equipment to required standards.
• Support procurement of spare parts and materials; minimise downtime and support manufacturing continuity.
• Maintain compliance with site procedures and regulatory requirements; support audits and inspections.

Conhecimentos

Site Engineering

Maintenance & Calibration

Equipment Validation

IQ OQ PQ Support

Planned Preventative Maintenance

Utilities Support

GMP / cGMP Compliance

Technical Troubleshooting

Contractor Management

Documentation & Record Keeping

Continuous Improvement

Cross-Functional Communication

Descrição da oferta de emprego

Our client, a well-established regulated manufacturing organisation based in Co. Kerry, is seeking a Site Engineer to join their team.

Reporting to the QA Lead for Production and Maintenance, this role will be responsible for supporting the maintenance, calibration, validation and continuous improvement of manufacturing equipment, instrumentation and site systems. The Site Engineer will work closely with Quality, Production, external contractors and regulatory bodies to ensure equipment, utilities and engineering systems are maintained to the required operational and compliance standards.

This is an excellent opportunity for a technically strong engineering professional who enjoys hands-on problem solving, working in a regulated manufacturing environment, and supporting the reliable operation of critical site equipment and utilities.

Responsibilities include but are not limited to:

Maintenance & Calibration

• Monitor, control and support maintenance activities for all manufacturing equipment and instrumentation on site.

• Ensure planned preventative maintenance schedules are followed and completed in line with site requirements.

• Maintain accurate maintenance, calibration and equipment records.

• Support troubleshooting and technical problem-solving across manufacturing equipment and site utility systems.

• Liaise with external subcontractors and service providers regarding equipment maintenance, calibration, qualification and repair activities.

Validation & Qualification

• Assist with IQ, OQ and PQ activities for new and existing equipment.

• Support the execution and documentation of equipment validation and qualification activities.

• Assist with the validation, calibration and maintenance of critical utilities including Purified Water systems, WFI systems, HVAC systems and autoclaves.

• Ensure engineering activities are aligned with the site Master Validation Plan.

• Maintain and update associated validation, maintenance and calibration documentation.

Engineering & Site Support

• Oversee the day-to-day engineering function to ensure manufacturing equipment and site systems are maintained to the required standard.

• Support the procurement and purchasing of spare parts, consumables and engineering-related materials.

• Work closely with Production and Quality teams to minimise downtime and support manufacturing continuity.

• Identify opportunities for equipment, process and site system improvements.

• Support continuous improvement initiatives across the manufacturing process in conjunction with the QP and wider site team.

Compliance & Documentation

• Ensure all engineering, maintenance, calibration and validation activities are carried out in accordance with site procedures and applicable regulatory requirements.

• Maintain accurate and compliant records relating to maintenance, calibration, validation and equipment performance.

• Support site readiness for audits and inspections.

• Liaise with regulatory bodies as required during audits, inspections and technical reviews.

• Ensure engineering documentation is completed accurately and in a timely manner.

Key Skills & Competencies

Site Engineering ;Maintenance & Calibration ; Equipment Validation & Qualification ; IQ, OQ & PQ Support ; Planned Preventative Maintenance ; Utilities Support ; GMP / cGMP Compliance ; Technical Troubleshooting ; Contractor Management ; Documentation & Record Keeping ; Continuous Improvement ; Cross-Functional Communication

What’s on Offer

• Opportunity to join a well-established regulated manufacturing organisation.

• Varied site engineering role covering maintenance, calibration, validation and utilities.

• Exposure to manufacturing equipment, instrumentation and critical site systems.

• Opportunity to work closely with Quality, Production and external technical partners.

• Long-term career development opportunity.

• Supportive team environment with strong cross-functional interaction.

• Immediate interviews available for suitable candidates.