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The Maintenance Technician - DP reports to the Maintenance Area Lead – DP & Pkg and is responsible for executing maintenance in a GMP compliant manner. The Maintenance Technician will primarily serve as an integral member of Maintenance Operations team in a Biologics Drug Product manufacturing facility, but with potential to work in all areas including manufacturing operations including Upstream & Downstream processing, Material Storage & Dispensing, Packaging, Drug Product Fill Finish, Clean & Plant Utility systems, WWTP and HVAC and reliability programs.
Job Responsibility:
Proactively maintain and troubleshoot drug product filling line equipment and parts preparation equipment in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the reliability agenda
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, design reviews and investigations
Flexible to work on day or 3 shift type roles
Requirements:
A relevant third level qualification in Engineering or time-served apprenticeship
3+ years’ experience in a GMP environment, preferably Bio-pharmaceuticals or equivalent industry with drug product fill finishing and packaging activities
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