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Dún Laoghaire, Éire / Ireland
Onsite
Primary Responsibilities:
The Senior Maintenance Technician will report to a Maintenance Manager and will work as part of one of the site maintenance teams (Process, Utilities, Lyophilisation, Inspection, Packaging) with the primary responsibilities laid out below. As the site expands, development opportunities may exist to transfer internally between teams and to gain experience with the equipment in each area of the plant mentioned above.
Equipment Maintenance
• Execute advanced maintenance activities on process equipment in accordance with standard operating procedures across multiple production and support facilities.
• Perform troubleshooting and equipment investigation works while assuring minimal impact to plant operations and in compliance with good maintenance practices, SOP’s and GMP requirements.
• Ability to work independently and as part of a team, taking responsibility for completion and handover of work, GMP documentation and ongoing maintenance of personal system qualifications.
• Demonstrated ability to participate in cross-functional teams to investigate non-conformances, deviations, and troubleshoot issues to establish root causes and corrective actions.
• Proactively integrate evolving technology and tools deployed as part of predictive maintenance strategies.
Projects and Continuous Improvement
• Support projects and start-up of new process plant and equipment.
• Support process investigations, trials, machine upgrades and testing in conjunction with the wider engineering team.
• Assist with the development, execution, and support of the CQV (Commissioning, Qualification, Validation) process.
• Identify and implement local projects to enhance equipment operation, reliability, and the efficiency of maintenance programs.
GMP and Compliance
• Maintain high levels of aseptic compliance and housekeeping standards in manufacturing areas, workshops and training areas whilst operating as part of a cross functional team to support the plant.
• Demonstrated ability to self-maintain online and practical training or qualification status in compliance with site operating procedures and key area metrics.
• Ensure activities are undertaken in a safe, compliant manner in accordance with legislative, site and corporate safety and quality procedures.
• Adopt compliance driven industry changes to document and record GMP activities.
Documentation
• Ensure that maintenance documentation and records are completed accurately and in accordance with applicable procedures such as ALCOA+ principles.
• Develop, revise & review relevant technical documents (Maintenance SOP’s, Job Plans, P&IDs etc.) in conjunction with the broader Engineering support team.
• Familiarity with the purpose and use of CMMS systems, Electronic Batch Records, and electronic logs or recording systems.
Primary Knowledge and Education:
• Recognised apprenticeship in an electrical / mechanical craft.
• Ability to read and understand mechanical drawings, technical manuals, electrical wiring schematics, layout drawings and P&ID’s.
Preferred Qualifications and Experience:
• Combined education, training and experience in mechanical / electrical maintenance, experience in a regulated manufacturing environment would be an advantage.
• Knowledge and experience working in a pharmaceutical or aseptic manufacturing facility.
• Understanding of pneumatic, mechanical, and hydraulic systems with the ability to effectively perform any associated maintenance or troubleshooting activities.
• Working knowledge and experience of site utilities and electrical systems.
• Relevant experience in an automated manufacturing and inspection environment would be an advantage.
• Experience executing and documenting maintenance work in a computerised maintenance management system.
• Ability to interpret P&ID's, identify hazards, isolation points and inter-dependencies between services for LOTO purposes.
• Ability to work with minimum direction, identify issues and effectively communicate the status of equipment or tasks in a timely manner.