לוטם בן אבו

Industrial Engineer with extensive experience in technological project management and Computerized System Validation (CSV). Skilled in regulatory compliance, process improvement and cross-functional collaboration. Knowledge of 21 CFR Part 11 and Annex 11 regulations, with a strong track record of delivering high-quality results in complex project.

CSV Engineer at Rotem Industries LTD (2024-01 – Present)

• Managed IT projects end-to-end, including planning, execution and user training.
• Developed efficient processes, mapped business needs and implemented risk management strategies.
• Led system testing, validation and smooth transitions during implementations.
• Delivered ongoing user support and training throughout project life cycles.
• Applied process improvement techniques and created monitoring tools.

IT Project Manager (2021-01 – 2024-12)

• Leading computerized systems validation, ensuring compliance with 21 CFR Part 11 and Annex 11.
• Writing, implementing and reviewing validation protocols (URS, VP, RA, IQ, OQ, PQ, and VSR).
• Managing data integrity, ensuring data reliability and adherence to regulatory standards.
• Updating SOPs and ensuring compliance with regulatory standards.
• Collaborating with cross-functional teams to align with validation and operational goals.

PMO at ELTA Systems Ltd (2018-01 – 2021-12)

• Oversaw multiple projects and ensuring KPIs (budget, quality, timelines) were met.
• Utilized MS Project, Excel and Visio for progress tracking and performance improvement.
• Led sprint meetings and coordinated cross-functional teams.
• Identified risks and escalated issues to ensure timely resolution.
• Prepared detailed reports for management and supporting decision-making.

Bachelor of Industrial Engineering and Management, specializing in information systems in Industrial Engineering and Management – Sami Shamoon College of Engineering (2016-01 – 2020-12)