Title: Maintenance Technician
Type: Contract
RESPONSIBILITIES
Proactively maintain process, utility and facility equipment in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the reliability agenda.
Maintenance and troubleshooting of equipment.
Interact with all process partners to continuously improve operations by recognising and correcting the causes of less than optimal equipment, facility and team performance.
Manage external vendor support to complete required services in a GMP compliant manner.
Perform problem solving including root cause analysis as required when equipment failures result in loss of production, substandard equipment performance and substantial repair cost and/or personnel safety incidents.
Ensure Electrical, Process and Utility Systems are maintained in a controlled state thus ensuring compliance with all procedures and regulations and reliability initiatives.
Maintain a safe working environment by continuously promoting safety awareness, recognising and rectifying unsafe conditions and performing thorough investigations when accidents occur.
Record all maintenance work performed on the site CMMS system.
Respond to critical utility alarms generated from the site automated alarm messenger system.
Maintain documentation and management and control systems in compliance with cGMP regulations and training instructions.
Where required complete and record calibrations activities completed on site and report any defects detected.
Contribute to the drive to effectively manage spares, consumables and contracts in a timely and cost effective manner.
Use of permit to work system or other safety systems to control engineering activities.
Participation in HAZOP and design reviews
SCOPE
This position ensures the Manufacturing, Quality Control, and Facilities equipment and instrumentation is maintained & operated in the calibrated state necessary to perform cGMP activities.
Maintenance Technician has scope to initiate process, cost and execute continuous improvement ideas.
EDUCATION AND EXPERIENCE
A relevant third level qualification in Engineering or time-served apprenticeship with 3+ years' experience in a GMP environment, preferably Bio-pharmaceuticals or equivalent industry with drug product fill finishing and packaging activities.