Site Engineer

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.

Job requirements

• Technical qualification in Engineering, Maintenance, Mechanical, Electrical, Instrumentation, Manufacturing, or a related discipline.
• Proven technical experience in a manufacturing, regulated production, utilities, maintenance, engineering or similar environment.
• Experience supporting maintenance and calibration of manufacturing equipment and instrumentation.
• Knowledge of planned preventative maintenance systems and maintenance documentation.
• Experience working with utilities such as purified water, WFI, HVAC, autoclaves, or similar systems would be advantageous.
• Experience supporting IQ, OQ, PQ, validation, calibration or qualification activities would be beneficial.
• Strong understanding of GMP, cGMP or regulated manufacturing environments would be an advantage.
• Ability to liaise effectively with external contractors, suppliers and service providers.
• Strong documentation, record-keeping and technical reporting skills.
• Good problem-solving ability and a practical, hands-on approach.
• Ability to work cross-functionally with Quality, Production and Management teams.
• Strong communication, organizational and time-management skills.

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.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other relevant opportunities.

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