Sr. CQV Specialist
The Sr. CQV Specialist at Legend Biotech is a key member of the Technical Operations team, responsible for providing Commissioning, Qualification, and Validation (CQV) support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, New Jersey. This role is integral to ensuring safe and compliant manufacturing operations in line with cGMP requirements, contributing to the production of personalized cell therapy products.
Key responsibilities include executing commissioning, qualification, requalification, validation, and associated maintenance activities within the plant. The specialist manages multiple complex CQV projects, collaborates with cross-functional teams, provides status reports, and coordinates with other departments or external contractors to complete tasks. Additionally, the role involves supporting or owning technical and quality investigations, CAPAs, and corrections, as well as developing and performing required remediation efforts and associated CAPA plans.
The ideal candidate holds a minimum of a Bachelor's Degree in Science, Engineering, or an equivalent technical discipline, with at least 7 years of relevant work experience. Experience in an aseptic manufacturing facility, preferably in cell therapy, testing facilities, quality assurance, or manufacturing compliance, is preferred. Proficiency in systems such as Microsoft Suite, ERP systems like Maximo, Siemens EMS, Comet, Kneat, and testing systems like Kaye AVS and Kaye Valprobe is advantageous. Strong interpersonal and communication skills, the ability to process complex information quickly, and proficiency in applying process excellence tools and methodologies are essential.
The base pay range for this position is $107,482 to $141,070 USD annually. Additional compensation may include performance-based bonuses and/or equity for eligible roles. Benefits offered include medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a comprehensive paid time off policy. Additional voluntary benefits encompass flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
Legend Biotech fosters a collaborative and innovative work environment, dedicated to treating and potentially curing life-threatening diseases through advanced cell therapies. Employees are encouraged to contribute to cutting-edge therapeutics for patients worldwide, with opportunities for professional growth and development within a dynamic and mission-driven organization.