Metrology Technician I/II

Company:

Legend Biotech

Job Overview

Legend Biotech is seeking a Metrology Technician I/II as part of the Technical Operations team based in Raritan, NJ. This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. 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 organization 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.

Key Responsibilities

• Providing technical expertise in support of an effective calibration program
• Planning and performing calibration and instrumentation activities
• Managing third-party vendor work
• Supporting shutdown calibrations
• Reviewing calibration outcomes
• Developing calibration data sheets and job plans
• Participating in emergency response and safety programs
• Managing SOPs, quality events, CAPAs, and Out of Tolerance situations
• Conducting risk mitigation and troubleshooting
• Optimizing calibration frequencies
• Defining user requirements for new instruments
• Supporting start-up, commissioning, and validation of instrumentation and systems
• Promoting a collaborative work environment with a focus on EHS and quality
• Participating in audits
• Managing contractor relationships
• Improving team metrics in EHS, quality, compliance, cost, delivery, and people

Job Requirements

Job duties require exposure to biological materials and hazardous chemicals. The role requires interaction with multiple organizational levels and departments.

Qualifications

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering or equivalent trade/technical certification
• Minimum 4+ years of cGMP cleanroom manufacturing experience
• Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs, electrical practices, cGMP compliance, EHS and regulatory standards
• Experience in a growth environment
• Strong communication and teamwork skills
• Ability to lead in a matrix environment
• Skills in project management, change management, operational excellence, continuous improvement, and lean manufacturing