Specialist, Aseptic Filling Technician

JOB SUMMARY:
At Resilience Biotechnologies Inc. (RESILIENCE), we’re specialists in biologics. In our two divisions; RESILIENCE Biomanufacturing, and RESILIENCE Innovations, our passion for quality and patient safety underpins everything we do. RESILIENCE Biomanufacturing is a global contract development and manufacturing organization (CDMO); RESILIENCE Innovations is devoted to drug discovery, and research and development. Our scientists are currently developing innovative protein therapeutics in anemia, liver cancer, and hepatitis C.

Under the guidance of a Supervisor, the Aseptic Filling Technician will operate and maintain equipment/suites used for the formulation and aseptic filling of product into vials or syringes. This position will follow GMPs/cGMPs, SOPs and all company policies/regulations.

MAJOR RESPONSIBILITIES:

- Set up and operation of Aseptic Filling Equipment, Filling/Capping machines, and Lyophilizers
- Prepare/sterilize components and manufacturing equipment using autoclave
- Perform Formulations and Filtration 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

MINIMUM 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

PREFERRED QUALIFICATIONS:

- Experience in sterile filling 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, occasional extended shifts, and possible short notice schedule shift changes
- Lifting/pushing/pulling up to 25kg
- Direct contact with alcohol/chlorine based disinfectant agents

BEHAVIOURAL:
Teamwork: Working effectively and productively with others.

Flexibility: Agility in adapting to change

Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types

Organization and Planning: Detail oriented, punctual, sense of urgency and accountability

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
- This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization._

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

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.