This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing facility. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of th... more details
Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Maintenance Specialist as part of the Technical Operations Department team based in Somerset, NJ.
Role Overview
This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing facility. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility. The role will require technical expertise and troubleshooting ability to drive effective and robust production, testing and release of product to patients.
Key Responsibilities
Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process equipment and systems
Utilizes knowledge and experience in plumbing, HVAC, Clean room HVAC, refrigeration, pipefitting, and millwright activities associated with the related mechanical systems, utilities, and process equipment
Perform minor upgrades and installations of facilities and systems
Perform on-site equipment 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. plumbing/pipefitting areas with journeyman status in at least one
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
Demonstrated ability to effectively troubleshoot, plan work and 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 of 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, motors with voltages up to 600 volts
Operate, monitor, and maintain switchgear
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
Complies with all company and/or site policies and procedures
Support maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s
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 accommodate changes in the schedule including working in other shifts and providing on call support as per operational needs is 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. NJ boiler license preferred.
Minimally 5+ 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
Preferred Knowledge and Skills
cGMP manufacturing
Maintenance, facilities and utilities
Computerized maintenance management systems (CMMS)
EHS and regulatory standards (e.g. EPA, OSHA and DEA)
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
#LI-Onsite
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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.