Quality Assurance Validation Specialist II

Role: QA Validation Specialist II within Global Quality Operations, supporting regulated biopharmaceutical assets and processes in cell and gene therapy, including clinical and commercial environments. Responsibilities: review and approve validation documentation (URS, protocols, reports), ensure compliance with GMP and QMS, serve as SME for validation activities across equipment, computerized systems, and facilities, and collaborate with cross-functional teams on validation and digital initiatives. Requirements: Bachelor’s in Engineering, Life Sciences, or related field; minimum 3 years' experience in Validation or QA within biopharma; strong understanding of validation lifecycle pillars, GxP CSV, equipment qualification (IQ, OQ, PQ), and GMP regulations. Preferred: experience in cell and gene therapy validation, audit participation, and validation of analytical and manufacturing processes. HighValue: focus on cell/gene therapy, GMP validation, validation lifecycle management, and regulatory compliance. WorkSetup: on-site in Stafford, TX; schedule 8 AM–5 PM, Monday to Friday.