Engineer, Computer Systems Validation & IT Compliance

What you'll do

• Execute computer system validation (CSV) and IT compliance activities for computerized systems and automation projects.
• Manage IT deviations, change controls, risk management programs, and root cause analysis within the Quality Management System.
• Support Data Integrity and Quality Risk Management programs to ensure regulatory compliance.
• Participate in internal and regulatory audits as a representative to help resolve audit observations.
• Develop and maintain GxP-related procedures, guidance documents, and other technical documentation.
• Track project progress using dashboards to meet schedules, reduce costs, and improve operational efficiency.
• Identify and implement improvements for CSV processes and evaluate new technologies or tools.
• Support the development of training materials and conduct training for relevant stakeholders.

What we're looking for

• Bachelor's degree in Engineering, Science, Information Technology, or a related IT/OT discipline.
• 1–3 years of relevant experience in Compliance and Computer System Validation (CSV).
• Experience in Cell Therapy, Biologics Manufacturing, or related life sciences (preferred).
• Working knowledge of regulatory CSV requirements including FDA, EMA, ICH Q7, Q8, and Q9.
• Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, and GAMP for automated systems.
• Working knowledge of ISO 9001 standard (preferred).
• Experience or training in performing internal audits and inspections (preferred).
• Proficiency in project management, technical writing, and Lean Six Sigma/OPEX principles.