Aseptic Filling Technician I
A career at Resilience is more than just a job – it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
The Aseptic Filling Technician I will operate and maintain equipment/suites used for the formulation, component preparation and aseptic capping of product filled and stoppered vials or syringes. This position will follow GMPs/cGMPs, SOPs and all company policies/regulations.
This is a 12-Month Fixed-Term Assignment. This is a Rotating Schedule that will include Days, Afternoons and Weekends, typically 8-hour shifts.
Major Responsibilities:
- Set up and operation of Aseptic Filling Support Equipment, Washing/Capping machines, and filling support activities
- Prepare/sterilize components and manufacturing equipment using autoclave/vial washer
- Perform Formulations, Filtration and Capping for Aseptic Filling
- Documents and records all necessary information/data as per SOPs and cGMPs.
- Performs all duties according to the SOPs and cGMPs and all other established Health & Safety standards.
- Cleaning of aseptic manufacturing areas/suites as per established procedure
- Notifies supervisor in the event of a manufacturing issue or any deviation from manufacturing and quality standards
- Performs all other job-related duties as assigned
Preferred Qualifications:
- Science Degree or Technical Diploma with relevant experience in pharmaceutical industry is required
- 2+ years of previous manufacturing experience in a GMP environment is required
- Experience in sterile process and/or aseptic manufacturing
Additional Requirements:
- Pre-employment medical, and medical re-examination performed every 2 years; including eye exam qualification, in accordance with RESILIENCE SOPs. Included as part of the medical is a respirator fit test (half and full mask), and pulmonary function test
- Occasional use of a half face respirator, and full-face respirator
- This position requires vaccination for Hepatitis A and B
- Gown qualified for sterile operations in Class A/B clean rooms
- Job requires shift work including weekends, rotating day/evening shifts, occasional extended shifts, and possible short notice schedule shift changes
- Lifting/pushing/pulling up to 25kg
- Direct contact with alcohol/chlorine based disinfectant agents
- Medical Information (Canada Only)
The items described here are representative of those that must be met successfully to perform the essential functions of this job. Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.