Scientist/Engineer

Duties and Responsibilities Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) using root cause analysis tools. Lead investigations and cross‑functional investigation teams; close reports in a timely manner. Perform GEMBA walks with stakeholders to understand process steps and evaluate root cause analysis. Propose CAPAs, develop CAPA plans, and assure CAPA effectiveness. Assess impact/risk of proposed changes and develop mitigation strategies; may initiate change control documentation. Identify functional SMEs to support impact assessments during change management. Ensure investigations are completed timely; notify stakeholders of delays. Provide technical support for manufacturing investigations, CAPAs, and change controls as needed. Support deviation investigation defense during audits and site inspections. Handle complex issues with minimal guidance. Provide training to new investigation team members. Serve as author or technical reviewer of departmental procedures as appropriate. Support manufacturing and Quality Control testing of CAR T products as needed. Apply lean manufacturing / six sigma principles to continuously improve. Required/Preferred Qualifications Working experience in deviation investigations using root cause analysis tools. Working CAPA process experience with ability to identify and verify effectiveness. Technical writing skills; ability to collaborate cross‑functionally. Ability to interpret/apply global regulatory and cGMP requirements; support health authority inspections. Knowledge of data trending/tracking; statistical analysis software a plus. Advanced problem‑solving, prioritization, timeline management. Experience using electronic quality systems (eQRMs a plus). Hands‑on experience preferred with CAR‑T or biopharmaceutical manufacturing and Quality Control. Education and Experience Bachelor’s degree in science or engineering (biochemistry/life sciences or related); advanced degree preferred. Minimum 3 years relevant experience in a health authority regulated environment. Biopharmaceutical manufacturing facility experience preferred (CAR T a plus). #J-18808-Ljbffr Scorpion Therapeutics