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.

• 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.

• 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).