Legend Biotech US

Maintenance Specialist I/II (Contractor)

Raritan, New Jersey, United States · Mid · Contract

Sponsorship not specifiedDetected 21 hours ago

Customer SupportPLCGMPFDA RegulatoryCollaborationOSHA

About the role

This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift.
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 for commercial launch and sustained production.

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.
Perform minor upgrades and installations of facilities and systems.
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.
Operate, monitor, and maintain switchgear.
Working knowledge of building automation systems, including PLC's, HMI's, sensors, and other components.
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 continuous improvement activities.
Operations, Quality, HSE, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering.

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.
Minimally 4+ 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 HVAC and cleanroom ma
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.
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.
Familiarity working with validated and qualified equipment, and associated documentation required.
Ensures regulatory and job training remains current by promptly completing required training.

Experience in the Pharmaceuticals or related industry is preferred.
Experience working in a controlled, cleanroom environment under aseptic conditions is preferred.

Support tracking and achievement of annual maintenance goals and objectives including metric improvement targets.

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.