Metrology Support Specialist
Legend Biotech is seeking a Metrology Support Specialist as part of the Technical Operations team based in Raritan, NJ.
Role Overview
This position will be responsible for metrology support for instrument and mechanical system scheduling, planning, and work order management for cGMP 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 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. This position will also be responsible for supporting, planning and scheduling facility & engineering related activities. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
Key Responsibilities
- Assist in Scheduling, planning, and organizing calibration activities with all department owners and specialists performing work.
- Backup to maintenance support specialist.
- Assist with CMMS reports to support scheduling, prevent overdue work, and build metrics for KPI’s.
- Possesses a general functional, mechanical and technical understanding of facility instrumentation, equipment and utilities.
- Handles a variety of facilities & engineering department administrative support activities.
- Supports scheduling for metrology and facility and project initiatives as needed which includes engineering, maintenance and validation projects.
- Utilizes 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.
- Supports maintenance goals and objectives including metric improvement targets. Support continuous improvement activities.
- Supports metrology driven quality events including but not limited to Non-conformance Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
- Ensures regulatory and job training remains current by promptly completing required training.
- Complies with all company and/or site policies and procedures.
- Demonstrates willingness to learn new skills as required.
- Available for other duties as required.
- Ensures 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 interact with all levels within the organization - Operations, Quality, HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering, Validation.
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 5+ years of experience in an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic condition.
- Experience with CMMS or similar maintenance management system is required.
- Experience in planning and scheduling of metrology activities is required.
- 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.
- Proficiency in English (verbal and written) and strong communication skills.
- cGMP manufacturing.
- Metrology, Maintenance, facilities and utilities.
- Computerized maintenance management systems (CMMS).
- Scheduling and planning.
- EHS and regulatory standards (e.g. EPA, OSHA and DEA).
- HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, 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.
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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.
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