#R-230765
• 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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