Sr. Maintenance Technician - Inspection & Packaging (24/7 Shift)

Biopharma Careers; Dún Laoghaire; On-site; EUR 52,000 - 72,000; Full time

Job summary

Biopharma Careers in Ireland seeks a Maintenance Technician to execute advanced maintenance on process equipment across production facilities, following SOPs and GMP requirements.

You will troubleshoot, document with ALCOA+ standards, participate in cross-functional investigations, support CQV activities, and contribute to continuous improvement of maintenance programs; read drawings and work independently or in teams.

Qualifications

• 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.

Responsibilities

• Execute advanced maintenance activities on process equipment across multiple production facilities.
• Perform troubleshooting and equipment investigation with minimal impact on plant operations and GMP compliance.
• Work independently or in a team, ensuring completion and handover of work and GMP documentation.
• Participate in cross-functional teams to investigate non-conformances and establish corrective actions.
• Support CQV activities and continuous improvement of maintenance programs.

Skills

Electrical maintenance

Mechanical maintenance

Troubleshooting

Documentation

GMP knowledge

Education

Recognised apprenticeship in electrical or mechanical craft

Tools

CMMS systems

Electronic Batch Records

P&IDs

Job description

Career Category

Maintenance

Job Description

Primary Responsibilities:

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.

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