Legend Biotech is seeking a Critical Equipment Expert as part of the Global Operations team based in Somerset, NJ.

Role Overview

This position will be responsible for calibration and maintenance support of mechanical system operations for cGxP Clinical Cell Therapy Manufacturing and R&D Laboratories. This individual will partner with various functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGxP requirements. They will require technical expertise and troubleshooting ability to support the Clinical Production Facility and R&D laboratories. This role will focus on critical operations equipment for reliability, calibration and PM completion, troubleshooting, scheduling, spare parts, and compliance to continually support site needs. This role supports operational activities, occasionally these activities will require support outside of the typically work schedule, which could include working in other shifts and providing on call support.

Key Responsibilities

• Manage critical operations equipment throughout its entire lifecycle including induction, reliability, Calibration and PM completion, troubleshooting, scheduling, spare parts, and compliance to continually support site needs.
• Laison between operations and facilities management for critical process equipment events and repairs
• Assist with investigations and projects referring to critical process equipment.
• Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, RODI generation, cryogenic storage equipment and all types of process equipment and systems
• Utilizes knowledge and experience in all types of HVAC, calibration, and maintenance of related mechanical systems, utilities, and process equipment
• Perform minor upgrades and installations of facilities and systems
• Perform on-site equipment calibration and maintenance, and critical utilities maintenance operations, and compliance. This includes but is 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 compliance to all applicable codes and regulations as required. Obtains and keeps current all required licensing and certifications associated with the job
• Possesses experience and training in reactive, preventive, and predictive maintenance of all mechanical, HVAC and refrigeration.
• Possesses experience and training in calibration and certification of equipment associated with the mechanical systems, utilities, and process equipment.
• Reads and interprets blueprints, P&IDs, and drawings
• Utilize good documentation practices (GDP) for all work performed on the CMMS system work orders. Completes all other work associated with the assignment working cooperatively with others
• Author and revise documentation including; procedures, work plans, change controls, impact assessments and deviations
• Demonstrated ability to effectively troubleshoot, plan work and anticipate potential problems and take appropriate actions
• Repair of instrumentation, electrical devices, circuits, and equipment used in cGxP and non-GxP systems
• Working knowledge of building automation systems, including PLC's, HMI's, sensors, and other components
• Familiarity working with validated and qualified equipment, and associated documentation required
• Familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory
• Ensures regulatory and job training remains current by promptly completing required training
• Support maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and CAPAs
• Demonstrates willingness to learn new skills as required
• Available for other duties as required
• Support tracking and achievement of annual maintenance goals and objectives including metric improvement targets. 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), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration
• Ability to work independently and with minimal guidance/oversight
• Ability to own, plan, facilitate and execute initiatives

Requirements

• Minimum of a High School diploma or equivalent required with relevant 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 equipment maintenance, calibration and certification is preferred
• Experience with CMMS or similar maintenance management system is required
• cGMP manufacturing
• Calibration, Maintenance, facilities and utilities
• Computerized maintenance management systems (CMMS)
• EHS and regulatory standards (e.g. EPA, OSHA and DEP)
• HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, automation PLCs, VFDs and electrical practices
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
• Strong analytical, problem solving and critical thinking skills
• Continuous improvement
• Excellent organizational and communication skills
• Technical writing

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.