QC Specialist, Equipment Management

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 QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. 

Role Overview

The Equipment Specialist is responsible for equipment lifecycle management and Quality Control (QC) systems administration.

Key Responsibilities  

• Lead activities such as equipment purchase, qualification, computer systems validation (CSV), troubleshooting, metrology, calibration, and maintenance.
• Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications.
• Maintain lab equipment in a validated state following established GxP regulations.
• Support system upgrades, maintenance, and rollouts of new systems, as needed and review/approve CSV documents including reviewing of Change Requests
• Collaborate with Quality Systems, IT, and site facilities to support ongoing instrument and applications troubleshooting, maintenance, retirement, and change management.
• Create change controls for new or existing equipment and initiate Quality Event Management events for equipment not meeting protocol requirements, as applicable.
• Ensure compliance to procedures, regulatory/HA requirements, and industry standards and maintain data integrity standards for all laboratory equipment and instrumentation.
• Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211, etc.)

Requirements

• A Minimum of Bachelor's or equivalent University degree required
• Minimum three (3) years of relevant work experience in pharmaceutical industry.
• Experience in a Regulated Quality environment and/or Engineering Equipment Development environment
• Experience with IQ, OQ, and PQ
• Capability to creatively problem-solve and troubleshoot, develop improvement ideas, and independently implement associated solutions with minimal guidance as a proactive change agent.
• Excellent written and verbal communication skills with the ability to communicate clearly and concisely with all levels.
• Experience with equipment purchase, CSV, metrology, calibration, and/or maintenance
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory.
• Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process
• This position will be located in Raritan, NJ and may require up to 5% of travel

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.