AAKIB AMANJI
Toronto,Canada
Summary
Detail-oriented and skilled pharmaceutical and laboratory professional with extensive experience in GMP-regulated manufacturing and sterile laboratory environments. Expertise includes aseptic handling, equipment setup and troubleshooting, MBR compliance, ERP data entry, and meticulous documentation aligned with data integrity and regulatory standards. Strong foundation in environmental monitoring, sterile sample preparation, and inventory management complements proficiency in operating and calibrating specialized equipment while ensuring adherence to EH&S policies, SOPs, and regulations (FDA, Health Canada). Committed to maintaining product quality, optimizing processes, and fostering collaboration within cross-functional teams to drive operational excellence in pharmaceutical manufacturing.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Production Operator - Vaccines (Upstream)
Sanofi Pasteur
02.2025 - Current
- Perform aseptic operations in cleanroom environments following GMP, GDP, and SOP standards to ensure product quality and compliance.
- Set up, operate, and maintain manufacturing equipment such as incubators, candlers, automated inoculators, cold boxes, and egg harvesting systems.
- Monitor process parameters (temperature, pressure, pH, humidity) using DeltaV, MES, or other control systems to maintain optimal production conditions.
- Conduct daily egg candling to assess embryo viability and detect contamination or defects.
- Accurately document all batch records, equipment usage, and cleaning activities in SAP, OpsTrakker, or paper logbooks to ensure traceability.
- Collaborate with Quality Control, Maintenance, and Engineering teams to troubleshoot issues and ensure smooth production flow.
- Perform routine cleaning, sanitization, and equipment calibration to maintain a sterile and controlled environment.
- Train new operators on production procedures, GMP documentation, and equipment operation.
Process Operator I
Teva Canada Limited
02.2024 - 01.2025
- Performed duties in accordance with the master batch record (MBR) and in compliance with EH&S policies, GMPs, and controlled procedures (SOP, EM, WI, JA, etc.)
- Completed all GMP documentation (MBR, controlled procedures, labels, logbooks, validation documentation, etc.) in accordance with Data Integrity, in their area of responsibility
- Performed ERP data entry and transactions, and verification checks as required
- Conducted intermediate troubleshooting: Optimizing all settings, parameters and adjustment of equipment within area of responsibility or process type
- Conducted intermediate equipment setup: Independently fully disassemble and set up equipment within area of responsibility or process type
- Calibrated weight scales to maintain required productivity levels and adherence to quality standards.
Pre-Analytical Laboratory Assistant
Bio Analytical Research Corporation South Africa
05.2020 - 08.2021
- Prepared, handled, and analyzed laboratory samples while strictly adhering to safety and aseptic protocols to prevent contamination
- Assisted in the preparation of media and reagents under sterile conditions, ensuring compliance with laboratory standards and procedures
- Monitored and maintained inventory of sterile supplies and materials, ensuring availability for ongoing experiments and projects
- Conducted daily and weekly cleaning of workspaces and equipment to maintain a sterile laboratory environment
- Utilized a range of laboratory instruments and equipment, ensuring all are sanitized and maintained according to sterile guidelines.
Education
Associate of Science - Biotechnology Advanced
Centennial College of Applied Arts And Technology
Toronto, ON06.2023
Bachelor of Science - Microbiology and Biochemistry
University of Venda
Limpopo, South Africa05.2020
Skills
- Cross-functional teamwork
- Experienced in GMP compliance
- Comprehensive documentation standards
- Aseptic Techniques / Sterile Handling
- Cleanroom Operations (ISO 5–8)
- DeltaV Process Control System
- Experience with MES optimization
- OpsTrakker Electronic Logbooks
- SAP (Batch & Inventory Management)
- Data monitoring expertise
- Environmental Monitoring (Temperature, Humidity, Pressure)
- Equipment Operation & Maintenance
- Batch record management
Certification
- Worker Health and Safety Awareness, Ministry of Labor, Training and Skills Development
- Certification in Workplace Hazardous Information System (WHMIS)
Additional Information - References
Available upon request
Timeline
Production Operator - Vaccines (Upstream)
Sanofi Pasteur
02.2025 - Current
Process Operator I
Teva Canada Limited
02.2024 - 01.2025
Pre-Analytical Laboratory Assistant
Bio Analytical Research Corporation South Africa
05.2020 - 08.2021
Bachelor of Science - Microbiology and Biochemistry
University of Venda
Associate of Science - Biotechnology Advanced
Centennial College of Applied Arts And Technology