Job Description

Legend Biotech is seeking a Maintenance Tech as part of Facilities and Engineering team based in Raritan, NJ.

This position is responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift (approximately noon–8:30pm). The individual will partner with various Technical Operations functions to support safe, compliant, personalized cell therapy production per cGMP requirements, and will support the organization’s build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. The role requires technical expertise and troubleshooting ability to drive effective, robust production, testing, and release of product to patients.

Key Responsibilities

• Diagnose, troubleshoot, repair, and maintain all types of HVAC, clean room HVAC, refrigeration, clean steam, cryogenic storage, and process equipment and systems, applying reactive, preventive, and predictive maintenance and knowledge of plumbing, pipefitting, and millwright activities across related mechanical systems and utilities, with journeyman status in at least one craft.
• Perform minor upgrades and installations of facilities and systems.
• Perform on-site equipment and critical utilities maintenance operations and compliance, including but not limited to support to manufacturing equipment projects, cost-improvement initiatives, asset management, reliability, and business operations.
• Support facility project initiatives as needed.
• Maintain knowledge of and comply with all applicable codes, regulations, and company and/or site policies and procedures.
• Obtain and keep current all required licensing, certifications, and regulatory/job training by promptly completing required training.
• Read and interpret blueprints, P&IDs, and drawings.
• Utilize good documentation practices (GDP) for all work performed on the CMMS system work orders.
• Demonstrated ability to effectively troubleshoot, plan work, anticipate potential problems, and take appropriate actions.
• Demonstrated ability to remove defective parts by dismantling equipment using hoists, scissor lift and manlifts, and hand and power tools.
• Repair instrumentation, electrical devices, circuits, and switchgear used in cGMP and non-GMP systems.
• Investigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation systems, electrical systems, controls, and motors with voltages up to 600 volts.
• Operate, monitor, and maintain switchgear.
• Working knowledge of building automation and environmental monitoring systems, including PLCs, HMIs, VFDs, sensors, and other components, and familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory.
• Familiarity working with validated and qualified equipment and associated documentation required.
• Support maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
• Support tracking and achievement of annual maintenance goals and objectives including metric improvement targets, and support continuous improvement activities.
• Ensure site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Agency (DEA), and Transportation Security Administration (TSA) as applicable.
• Ability to work independently with minimal guidance/oversight.
• Ability to accommodate changes in the schedule including working in other shifts and providing on call support as per operational needs.
• Ability to interact with all levels within the organization.
• Demonstrates willingness to learn new skills, works cooperatively with others, and is available for other duties as required.

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or minimum of a High School diploma required with equivalent experience.
• Trade / Technical School Certification or Certification in Craft required.
• Military equivalent of Trade / Technical School certification.
• Minimally 8+ years of experience in an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions.
• Proficiency in more than one craft.
• Experience in the Pharmaceuticals or related industry is preferred.
• Experience working in a controlled, cleanroom environment under aseptic conditions is preferred.
• Experience in HVAC and cleanroom maintenance is preferred.
• Experience with CMMS or similar maintenance management system is required.
• Proficiency in English (verbal and written) and strong communication skills.
• Able to manage shifting priorities to meet critical deadlines in a fast paced, dynamic, and growing environment, with strong analytical, problem solving, critical thinking, and organizational skills.

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