Mohamed Elgendy
Validation Expert
Ismailia
Summary
Experienced electrical engineer with a strong background in validation and calibration in the pharmaceutical industry. Thrives in collaborative team environments. Deep understanding of industry best practices, skilled at ensuring compliance and optimizing operational efficiency. Proven track record of delivering high-quality results, dedicated to driving innovation and exceeding expectations in every project.
Overview
11
11
years of professional experience
1
1
Language
Work History
Validation Unit Head
Minapharm Pharmaceuticals
10.2024 - Current
- Perform equipment qualification tests (IQ,OQ and PQ)
- Plan and implement the Computer Systems Validation (CSV) for all available computerized systems according to GAMP 5 & 21 CFR Part 11 data integrity rules
- Perform HVAC qualification tests for all clean rooms
- Perform all required PQ tests for LAFs and Pass boxes
- Supervise all activities performed by external suppliers and review protocols and reports like: Thermal validation for autoclaves, ovens, tunnels and Tanks SIP
- Thermal mapping studies for warehouses, refrigerators and incubators
- Steam quality and Compressed gases qualification tests
- Prepare all required SOPs, protocols and reports for all validation activities
- Prepare the validation calendar plans and index annually
- Any other tasks within the scope of validation department duties assigned by validation manager
- Continually improve methods and procedures for processes, measurements, documenting and work flow techniques
- Review documents compliance with different pharmaceutical guidelines and facing internal and external auditors
Calibration & Validation Supervisor
Egypt Otsuka Pharmaceuticals
12.2022 - 10.2024
- Responsible for review, and supervise the proper framework that governs the calibration & qualification activities within the organization Quality Management System
- Mainly responsible for reviewing, supervise, and reporting of the following: All calibration activities
- Autoclave validation
- Steam quality test qualification
- Compressed air quality test qualification
- Vacuum chambers qualification
- Light intensity qualification
- All Pass boxes qualification
- All external activities done by the outsourcing and archive reports
- Participate in SOPs & protocols reviewing and modifying
- Prepare the validation & calibration calendar plans and index annually, validation protocols and reports
- Any other tasks within the scope of validation department duties assigned by validation section head
- Continually improve methods and procedures for processes, measurements, documenting and work flow techniques
- Review documents compliance with different pharmaceutical guidelines and facing internal and external auditors
- Responsible for calibration and validation team training
Calibration & Validation Engineer
Medical Union Pharmaceuticals - MUP
03.2018 - 12.2022
- Perform IQ & OQ & PQ tests for any new equipment
- Perform PQ tests for existing equipments& processes like: All classified areas qualification
- Autoclaves & Ovens & Tunnels validation
- Refrigerators temperature mapping qualification
- Incubators temperature & relative humidity mapping qualification
- Thermal mapping studies for warehouses
- LAFs validation
- Compressed air quality test
- All AHUs HEPA filters Integrity tests in coordination with the engineering department
- Pass boxes validation
- Perform all calibration processes for instruments like (Flow meters, Temperature sensors, Pressure gauges, Balances, Thermo hygrometers, etc)
- Create & modify protocols, SOPs, qualification documents, test plans and test reports for quality assurance purposes
- Prepare the Validation Master Plan and Calibration plan annually
- Supervise for all external calibration activities done by the external suppliers
- Continually improve methods and procedures for processes, measurements, documenting and work flow techniques
- Review documents compliance with different pharmaceutical guidelines and facing internal and external auditors
- Responsible for all calibration and validation team training
Production & Maintenance Engineer
Medstar for plastic products
02.2016 - 02.2018
- Responsible for making sure manufacturing equipments and production processes run safely and cost effectively
- Perform preventive maintenance plan for the machines
- Repair all machines troubleshoots
Energy Efficiency & Renewable Energy Engineer
Eco business consultant
08.2014 - 05.2015
- Participate in evaluating 'the project of energy efficiency in street lighting' which was held by the Ministry of Electricity to save energy and improve the performance of street lighting
Education
Bachelor Of Engineering - Electrical Power And Machines Engineering
Elshorouk Academy
Cairo, C 01.2011 - 07.2011
Skills
- TQ Soft Thermal Validation System
- ELLAB Soft Thermal Validation System
- Madgetech Data Logger Software
- Tinytag Data Logger Software
- DIALux
- Electrical AutoCAD
- ETAP
- MATLAB
- Microsoft Office
Training
- Computer System Validation training course, EOP, 10th of Ramadan, Egypt, 01/01/24
- Balances & masses metrology and uncertainty calculations, NIS, Giza, Egypt, 12/01/23
- Thermocouples calibration, NIS, Giza, Egypt, 11/01/23
- Pressure gauges calibration, NIS, Giza, Egypt, 10/01/23
- Safety training, Atyab, Ismailia, Egypt, 12/01/15
- Electrical safety awareness seminar, ECC, Ismailia, Egypt, 12/01/15
- Electrical power systems distribution (Electrical wiring design), Jelecom, Elmansoura, Egypt, 09/01/12
- Electrical AutoCAD course, Jelecom, Elmansoura, Egypt, 09/01/12
- Training course, Elkanah company for electricity distribution, Ismailia, Egypt, 07/01/11
- Summer training course, electricity generation station in Abo sultan, Ismailia, Egypt, 07/01/09
Personal Information
- Date of Birth: 06/08/1988
- Nationality: Egyptian
- Marital Status: Married
Military Status
Exempted
Timeline
Validation Unit Head
Minapharm Pharmaceuticals
10.2024 - Current
Calibration & Validation Supervisor
Egypt Otsuka Pharmaceuticals
12.2022 - 10.2024
Calibration & Validation Engineer
Medical Union Pharmaceuticals - MUP
03.2018 - 12.2022
Production & Maintenance Engineer
Medstar for plastic products
02.2016 - 02.2018
Energy Efficiency & Renewable Energy Engineer
Eco business consultant
08.2014 - 05.2015
Bachelor Of Engineering - Electrical Power And Machines Engineering
Elshorouk Academy
01.2011 - 07.2011
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