Lead Maintenance Technician (Shift)

Summary:
Our client, a pharmaceutical company based in Carlow, is looking for a Lead Maintenance Technician. The ideal candidate will ensure the various maintenance and operations related tasks are effectively performed and that objectives are effectively achieved, consistent with our client’s requirements to ensure compliance, safety and reliable supply.

Responsibilities:

• Coordinate and execute maintenance activities, preventative maintenance, calibration equipment improvement projects, to ensure optimum equipment uptime and target outputs.
• Equipment will include everything within Operations Engineering responsibility, yet is not limited to, parts washers, autoclaves, portable tank CIP/SIP/storage panels, vial washer, depyrogenation tunnel, debagger filling and inspection machines.
• Ensure that all planned maintenance and calibration are complete to the schedule.
• Collaborate with operations colleagues and non-operations colleagues, particularly Quality, EHS, Technical Engineering, in completion of tasks to ensure best practice outputs e.g. partner with validation, maintenance and production operators in the investigation of equipment performance issues.
• Work under the guidance of the Coaches and LSS Engineers to apply lean tools to process data to complete improvements.
• Coordinate scheduled, tasks and resources in operations and cross functionally, including vendor management, communications, training, project work, audit/inspection duties.
• Coordinate clean room, mechanical spaces and workshops engineering housekeeping and materials management in all areas while focusing on continuous process improvement using Lean Principles.
• Manage equipment flow, through maintenance cycles.
• Review and post execution approval of preventative maintenance, corrective maintenance and calibration SAP work orders.
• Approval of change controls, ECM’s, QN’s and CAPA’s.
• Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
• Effectively manage and schedule equipment shutdowns, ensuring resources are available, thereby minimizing downtown.
• Ensure effective participation in writing/revising/ rolling out accurate, SAP task lists, technical engineering reports, training documents and maintenance procedures for various operations systems; ensure all work is carried out in line with same.
• Ensure equipment reliability and performance by ensuring root cause analysis is performed and subsequent recommendations and improvement changes throughout processes are implemented including the calibration of equipment as necessary.
• Troubleshoot equipment problems, identify need for new equipment and/or modifications to existing equipment to optimize throughput and reduce process cycle times.
• Drive change through Change control system in line with deadlines.
• Leadership activities including selection, development, coaching and day to day management.
• Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role.
• Develop and maintain training programmes.
• Required to comply with our client’s Global Policies, Procedures and Guidelines, Regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Identifies and facilitates the implementation of new job aids, error proofing and improvements to existing training programs.
• Responsible for the value stream training and cross training.

Qualifications & Experience:

• Time served apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
• Relevant experience in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Sterile filling processes and equipment.
• Understanding of mechanical/electrical/pneumatic processes.
• Knowledge of cGMP and GDP preferred.
• Troubleshooting and maintaining process instrumentation and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• SAP knowledge and experience preferred.
• Report, standards, policy writing skills required.
• Lean Six Sigma Methodology experience desired.