Full-Time

Maintenance Specialist

Posted on 8/28/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Senior

Bridgewater Township, NJ, USA

Category
Lab & Research
Life Sciences
Medical Research
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
  • 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
  • Transparent, Passionate, Fearless and Accountable
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, costimprovement 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 hours from approximately noon to 8:30pm
  • 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.

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Company Stage

IPO

Total Funding

$146.4M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.
  • New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.
  • Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

What critics are saying

  • Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.
  • Collaboration with Multiply Labs may face technological challenges, delaying production timelines.
  • Financial strain from new R&D facility could affect operational focus if advancements lag.

What makes Legend Biotech unique

  • Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.
  • The company is technology agnostic, exploring multiple platforms for effective cancer treatments.
  • Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

INACTIVE