Sr. QA Validation Specialist, CSV & Equipment
The Sr. QA Validation Specialist, CSV & Equipment at Legend Biotech is a key member of the Quality team, responsible for overseeing validation and qualification activities for equipment, systems, computer systems, and processes within the cell therapy manufacturing plant in Raritan, New Jersey. This role ensures compliance with both clinical and commercial requirements in a sterile GMP environment, contributing to the company's mission of developing advanced cell therapies for life-threatening diseases.
Key responsibilities include providing quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, as well as shipping validation and data integrity. The specialist will review and approve qualification and validation documentation, such as specifications, protocols, and reports, and offer expertise on industry best practices and quality requirements. Additionally, the role involves developing validation-related policies and procedures, ensuring data integrity, and collaborating with Quality and Technical Services colleagues to assess and guide system deployments.
Candidates must possess a minimum of a Bachelor's Degree in Science or a related technical discipline, along with at least 7 years of relevant work experience. Experience in an aseptic manufacturing facility, particularly in quality assurance, manufacturing compliance, clinical quality, or cell therapy, is preferred. A strong understanding of cGMP regulations, FDA/EU guidance related to GMP manufacturing of biopharmaceuticals, and GxP compliance is essential. The role also requires experience with cGMP regulatory body audits, strong interpersonal and communication skills, and the ability to work independently while managing multiple projects.
The base salary for this position ranges from $123,605 to $162,232 USD annually, with actual compensation varying based on experience, skills, qualifications, and geographic location. Additional compensation may include performance-based bonuses and/or equity for eligible roles. Benefits offered to permanent full-time employees 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 are also available, reflecting Legend Biotech's commitment to employee well-being and satisfaction.
Legend Biotech fosters a collaborative and innovative work environment, dedicated to treating and curing life-threatening diseases through advanced cell therapies. Employees have the opportunity to contribute to cutting-edge research and development, with growth opportunities within a rapidly expanding global biotechnology company. Joining Legend Biotech means becoming part of a team that values empowerment, support, and the pursuit of excellence in improving patient outcomes worldwide.