Aseptic Filling Specialist
$45,000–$56,250 year
On-site · Mississauga, Ontario, Canada
Job Summary
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 management and vendor relations; 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 IQ, OQ, and 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.
Required Qualifications
- 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 lift and carry materials up to 20 lbs and handle sensitive equipment
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