CQV Specialist

We are seeking a highly skilled CQV Specialist to join our team at Spark Life Solutions, Inc. The ideal candidate will have a strong background in cell therapy commissioning, validation, and qualification, with experience in managing complex projects and ensuring compliance with regulatory requirements.

• Execute commissioning, qualification, requalification, validation, and maintenance activities for plant contractors and vendors.
• Manage multiple and complex CQV projects, providing status reports and coordinating with other departments.
• Support CQV correction activities related to technical and quality investigations, CAPAs, and corrections.
• Author and execute master and completed CQV protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Support the revision and review of CQV-related SOPs and other technical documentation as required.
• Collaborate with Quality, Manufacturing Operations, Facilities & Maintenance teams.

• Bachelor's degree in science, engineering, or equivalent technical experience.
• CQV cell therapy and engineering experience required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products, as well as Good Tissue Practices.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to summarize and present results, and experience with team-based collaborations.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 required, and 600, 601, and 610 preferred.
• Experience authoring and executing documentation, including batch records, SOPs, work instructions, and CQV protocols.
• Experience with TrackWise, CMMS, and Maximo.
• Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).