Maintenance Technician (Drug Product)

at  Biomarin

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

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.

ONSITE ROLE

The Maintenance Technician reports to the Maintenance Area Lead and is responsible for executing maintenance and troubleshooting activities in a GMP compliant manner. The Maintenance Technician maintains equipment in the following areas; Drug Product Fill Finish, Packaging & Clean & Plant Utility system and HVAC.
The Maintenance Technician will serve as an integral member of Maintenance Operations team in a Biologics drug substance and product manufacturing facility.

RESPONSIBILITIES

• Proactively maintain and troubleshoot drug product filling line and packaging 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 and design reviews
• Flexible to work on day or shift type roles.