Aseptic Filling Specialist

Job Description
Union:  Non-Union
New or Replacement:  New
Department:  Manufacturing
Site:  2400 Skymark Ave. Unit 3, Mississauga, Ontario

Reports to:

Pharmaceutical Solution Manufacturing Supervisor
Wage Range:  $60,000 - $75,000 annually

Hours:

37.5 Hours per Week
Status:  Permanent Full-time
Number of vacancies:  2
Closing date:  June 16, 2026

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 management, vendor relations, and 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.

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 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.

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