Work Location: 3505 Laird Road, Mississauga
Department: Manufacturing
Reports to: Pharmaceutical Solution Manufacturing Supervisor
Work Model: On-site
Status: Permanent Full-time
Closing date: December 17, 2025
Duties and Responsibilities:
- Operate aseptic filling equipment to ensure accurate and sterile filling of products.
- Perform routine cleaning and sanitization of equipment and work area to maintain a cleanroom environment.
- Conduct in-process checks and environmental monitoring.
- Troubleshoot and resolve technical issues with aseptic filling equipment.
- Record and maintain accurate documentation of the production process, including batch records and logbooks.
- Follow safety protocols to prevent contamination and ensure the safety of all personnel in the aseptic environment
- Assist with inventory managements / vendor relations / order placements.
- Perform process troubleshooting and root cause analysis specific to buffer solution manufacturing and aseptic filling, addressing deviations and ensuring continuous improvement.
- Participate in validation and qualification activities for manufacturing processes, equipment, and facilities, in accordance with regulatory requirements and company guidelines.
- Assist in developing and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Identify opportunities for process optimization, innovation, and cost reduction.
- Must be able to work in a sterile, controlled cleanroom environment.
- Performs all other job-related duties as assigned.
- Undergraduate degree in chemical process engineering, pharmaceutical Sciences, Microbiology, Biotechnology, chemistry, biochemistry or related field.
- Minimum of 2-3 years of experience in aseptic filling, sterile manufacturing, or a related role in a laboratory or pharmaceutical manufacturing.
- Experience with cleanroom gowning and aseptic techniques.
- Strong interpersonal and communication skills with the ability to work independently and collaborate effectively with cross functional teams.
- Excellent analytical and problem-solving skills, with a keen attention to detail.
- Knowledge of aseptic processing, GMP, and regulatory compliance (FDA, EMA).
- Proficiency in statistical analysis and experimental design (e.g., Design of Experiments) is beneficial but not mandatory.
- Ability to work in a sterile, controlled cleanroom environment. Comfortable with standing for extended periods.
- Ability to lift and carry materials up to 20 lbs and handle sensitive equipment.
