QA Validation Specialist II LVV

Role: QA Validation Specialist II LVV at Janssen Pharmaceuticals, focused on quality oversight of cell bank production, cryopreservation, and viral vector testing within a cGMP environment. Responsibilities include review of environmental monitoring, validation activities, equipment qualification, calibration, and deviation investigations, ensuring compliance with GMP, ISO standards, and regulatory requirements. The role involves supporting contamination control, HVAC performance, and computerized system validation, maintaining audit-ready records, and facilitating continuous process improvements. Requirements: Bachelor's degree in Engineering, Science, or a related field; minimum 2 years of experience in regulated manufacturing, preferably in biotech or pharma. Knowledge of cGMP, FDA/EU guidelines, and experience with cell and gene therapy manufacturing, including quality support for clinical or GMP operations, are preferred. The position is based in Raritan, NJ, with occasional travel up to 5%, and involves working 8-hour shifts with some off-shift or weekend support. High-value specifics include involvement in biologics or cell/gene therapies, working within a GMP regulated environment, and supporting quality assurance functions critical to innovative medicines development.