Process Engineer North Carolina
Resume:
Beshoy Saadan Shabeb
Production operation, Process Engineer, Quality Compliance
*************@*****.***
Raleigh, NC
Green Card Holder
Male
linkedin.com/in/beshoy-shabeb-924979aa
Education
09/2004 – 06/2009
Cairo, Egypt
Bachelor Degree in Pharmacy
6th October Univerity
09/2001 – 06/2004
Cairo, Egypt
High School
Greek Catholic Patriarchal College
Professional Experience
01/2024 – present
North Carolina, USA
Quality Compliance Specialist
Pfizer
Aseptic Manufacturing Excellence Program
-Designed and delivered: A comprehensive Aseptic Shop Floor Coaching Program for traditional aseptic lines, RABS, isolators, and CFE, focusing on enhancing aseptic manufacturing practices.
- Improved contamination control and regulatory compliance: Utilized the coaching program to mitigate contamination risks, increase aseptic manufacturing knowledge, and drive regulatory compliance.
- Collaborative approach: Worked closely with the training department and Subject Matter Experts (SMEs) to identify vulnerabilities, develop targeted plans, and address learning gaps.
- Data-driven insights: Gathered and analyzed data from the aseptic coaching program and Environmental Monitoring (EM) data to inform process improvements.
- Process oversight and support: Conducted regular shop floor observations to ensure conformance to procedures and provided support for aseptic process simulations (media fills), smoke studies, and hypercare for new sterile manufacturing processes.
- Implementation of improvements: Successfully implemented improvements across the site, driving a culture of excellence in aseptic manufacturing. 03/2023 – 12/2023
North Carolina, USA
Aseptic Coach
EMMA International
Internal audit inside the core (class B)for inspection include but not limited to:
• Behavior • Item expiry dates • Cleaning
• Comparing SOPs with actual procedures and modify
• Conduct trainig to discuss the ways to improve the process
• Check for the gowning steps and gowning in general• Observe interventions and coach operators about any unfollowed behaviour or techniques 07/2017 – 12/2021
Giza, Egypt
Pharmacist Aseptic Production Manager
EVAPharma
-Established Antibiotic ( I.V/I.M Parentral) factory
-Leadership and Team Management: Provides direction and leadership to the aseptic manufacturing team, including hiring, training, and performance management .
- Process Oversight: Ensures the successful execution of aseptic manufacturing processes, including batch record review, equipment preparation, and sterilization . Beshoy Saadan Shabeb *************@*****.*** 1 / 3
- Quality Assurance: Ensures compliance with quality standards, regulatory requirements, and GMP guidelines .
- Equipment Maintenance: Oversees the maintenance and calibration of production equipment to ensure proper functioning and prevent contamination .
- Training and Development: Develops and implements training programs for aseptic manufacturing personnel to ensure they have the necessary skills and knowledge .
- Continuous Improvement: Identifies areas for process improvement and implements changes to increase efficiency, productivity, and quality .
- Regulatory Compliance: Ensures compliance with regulatory requirements, such as FDA guidelines, and participates in audits and inspections.
- Communication and Collaboration: Collaborates with other departments, such as quality assurance, regulatory affairs, and research and development, to ensure alignment and effective communication.
*Validation Experience:*
- Developed and implemented automated CIP/SIP and manual COP cleaning procedures.
- Established process parameters for equipment qualification, cleaning process development, sampling, and test/analytical methods.
- Determined residue limits and developed sampling techniques and methods. 06/2013 – 06/2017
Giza, Egypt
Pharmacist Aseptic Production Supervisor
Chemipharm
•Establish Freeze Dryer production line project
-Managed the production of various pharmaceutical products, including eye drops, ampoules, vial freeze-dried products, and cephalosporin vials. LEAD MEDIA FILL FOR ( Feeze dryer- eyedrop suspension and regular eyedrop products- powder product)
- Collaborated with Engineering, Microbiology, and Planning departments during filling operations, machine breakdowns, and repairs.
- Coordinated disinfection, cleaning, fumigation, and FOG(VHP) programs for the clean room.
- Developed and implemented batch records, SOPs, and training programs for new employees.
- Supervised lyophilization activities, including recipe conformity, vial loading/unloading, and cycle management.
Projects
09/2018 – 08/2019 EVAPHARMA Establishing Antibiotic I.V / I.M Factory
(Cephalosporin sterile powder injection)
- Spearheaded the launch of cephalosporin aseptic filling line, ensuring successful SAT, PQ, and media fill.
- Prepared and executed media fill protocols, a critical step before production commencemenT through the follwoing:.
A- Equipment Qualification and Validation:
1. Autoclave:
- Validated built-in cycles and modified them as needed.
- Create new cycles for media fill tank preparation for sterilization of 50 Liters of TSB & cooling cycles
- Collaborated with validation team to validate previous cycles & create required SOPs. Autoclave.
2. Filters and Filter Integrity Testers:
- Selected suitable filters (hydrophilic and hydrophobic) . Create their tests on Pall Integrity tester. Developed SOPs for operation.
3. Vial Washer Machine:
- Validated built-in cycles for different vial sizes.
- Modify cycles based on vial inner surface area.
- Collaborated with validation team to validate modifications. - Develope Related SOPs. Beshoy Saadan Shabeb *************@*****.*** 2 / 3 4. De-Pyrogenation Tunnel:
- Optimized tunnel conveyor belt speed, differential pressure, and cooling zone aeration.
- Adjusted gate height and validated modifications through thermal mapping. - Develop related SOPs
5. Filling Machine: (100% IPC)
- Created recipes for each powder type.
- Optimized M/C setup. minimized critical steps.
- Ensured differential pressure and relative humidity control by dedicated de- humidifier for filling zone
- Validated HEPA filters and performed smoke studies. - Develope Related SOPs B- Production and Quality Assurance:
- Managed commercial production for cephalosporin products.
- Coordinated with toll manufacturers for monthly and yearly production plans.
- Developed and implemented site-wide SOPs and log books.
- Ensured compliance with internal and external audit requirements. C- Training and Team Management:
- Trained team members on machine operations, aseptic gowning, and behavior.
- Conducted training on room disinfection and environmental monitoring. D- Disinfectant Management:
- Selected and replaced disinfectants based on environmental monitoring trends.
- Optimized disinfectant concentration based on micro results.
- Collaborated with cross-functional teams to design and implement sterile area infrastructure, layout, and equipment, including air handling units, dehumidifier systems, and CCTV systems.
- Managed budgeting for startup and stock building.
- Conducted machine quotation reviews and final observation reports for Bausch and Strobel filling lines of pre filled syringes/ vials/ampoules.
- Procured equipment and materials, including passive tanks, hoses, garments, and filters.
- Coordinated gamma sterilization of raw materials and created material and personnel flow layouts.
*Achievements:*
- Successfully passed MOH audit for licensing cephs plant.
- Achieved Tons of 3 consecutive media fill vial size 10R/20R/30R passes. 08/2015 – 05/2016 CHEMIPHARM Establish Freeze dryer Project
•Approve lay outs,SAT & PQ
•Operation, Validation, Media Fill, Commercial
•Production planing
Courses
Certified Six Sigma Green Belt
Coursera
Certified Six Sigma Black Belt
ASQ
Dedicated to preparing for the Certified Six Sigma Black Belt (CSSBB) exam from ASQ, with a focus on achieving certification.
Beshoy Saadan Shabeb *************@*****.*** 3 / 3
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