Specialist, Manufacturing

Resilience•Mississauga, ON

33d•CA$24 - CA$35•Onsite

About The Position

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 Specialist, Manufacturing performs upstream and downstream manufacturing operations in a cGMP biopharmaceutical environment. Operating under the guidance of the Supervisor, Manufacturing, this role supports both clinical and commercial production, ensuring all operations are conducted in strict accordance with safety, quality, and regulatory standards. Responsibilities include executing batch activities with high precision, maintaining rigorous documentation, and contributing to site-wide continuous improvement and safety initiatives.

Requirements

Demonstrated understanding of cGMP documentation requirements, data integrity principles, and regulated manufacturing procedures.
Ability to operate bioprocessing equipment and execute procedures (CIP/SIP, filtration, materials receipt/FIFO) following approved SOPs/WINs.
Ability to recognize routine process or equipment issues and confer with Management to confirm the appropriate course of action.

Nice To Haves

Bachelor's Ddegree or Technical Diploma in Biochemistry, Biotechnology, Biology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with exposure to bioprocessing techniques through coursework, co-op, or internship.
2+ years of experience in a biopharmaceutical, pharmaceutical, or CDMO manufacturing environment, ideally in upstream or downstream processing.
Hands-on experience operating chromatography systems (AKTA Ready or equivalent), cross-flow filtration (UF/DF/TFF), nanofiltration, and bioreactors.

Responsibilities

Operates manufacturing equipment and performs associated processing operations, including: Bioreactors, centrifuge, Bio Safety Cabinets (BSC) Chromatography skids UF/DF, TFF systems, as well as nanofiltration systems
Performs filtration using various methods and filter sizes
Proficient in aseptic techniques and practices allowing for contamination control in manufacturing spaces.
Executes CIP/SIP (Clean-in-Place/Steam-in-Place) on process skids and vessels
Performs in-process sampling and basic analytical tests
Participates in upstream and downstream manufacturing operations across the production process.
Utilizes HMIs and computerized systems to operate various skids and production equipment.
Performs all duties according to the SOPs/WINs and cGMPs and all other established safety standards and company policies.
Maintains housekeeping standards in the manufacturing area including cleaning of the process suites as guided by internal procedures.
Documents and records all necessary information/data as per SOPs/WINs and cGMPs requirements.
Identifies and escalates product/material defects, process deviations, or equipment issues to Management.
Supports continuous improvement initiatives by identifying and communicating process, equipment, or documentation issues to Management.
Acquire and maintain all required certifications and qualifications for the assigned work area, including visual inspection qualification and cold room training.
Cross-train and support other work areas as needed.