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.
For more information, please visit www.resilience.com
The Specialist, Inspection & Packaging performs Fill Finish manufacturing operations in a cGMP biopharmaceutical environment, including Grade A (ISO Class 5) and Grade B (ISO Class 7) sterile environments. Operating under the guidance of the Supervisor, Inspection & Packaging, 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.
Job Responsibilities
Operations
- Operates manufacturing equipment and performs associated processing operations, including:
- Vial washing and Depyrogenation Ovens
- Sterile environment Grade B/ISO Class 7 gowning and aseptic behavior’s qualification
- Cleanroom and component preparation for batch execution
- Cappers within the Grade B/ISO Class 7 environment in full sterile gowning
- Performs in-process sampling as per batch requirements
- Qualification for manual visual inspection of Product filled vials
- Qualification for manual visual inspection of Media filled vials
- Routine manual 100% visual inspection of media and final drug product
- Labelling and Packaging of final good drug product ready to release
- Participates in aseptic manufacturing operations across the Fill Finish production process.
- Utilizes HMIs and computerized systems to operate various equipment.
Compliance & Documentation
- 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.
Quality & Continuous Improvement
- 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.
Training & Development
- 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.
Minimum Qualifications
- Demonstrate understanding of cGMP documentation requirements, data integrity principles, and regulated manufacturing procedures.
- Proficiency in accurate batch record completion and Good Documentation Practices.
- Ability to recognize routine process or equipment issues and confer with Management to confirm the appropriate course of action.
Preferred Qualifications
- Bachelor's Degree 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
Physical & Work Environment
- Adhere to EHS policies, procedures, and standards, ensuring hazards are identified and risks are minimized to maintain a safe work environment.
- Physical demands may include standing for extended periods, ability to lift up to 20 KG, and working in cleanroom environments with appropriate gowning requirements, including full sterile gowning.
- Required to wear Personal Protective Equipment (PPE), including a fitted respirator; facial hair must not interfere with the face seal of a respirator in accordance with applicable safety standards and fit-test requirements.
- Production suite (floor, walls, and ceiling) must be cleaned as per required frequency based on approved procedure.
- Use of extendable mop handle as per approved procedures might be required based on production suites dimension.
- Requires pushing/pulling racks with vials in stainless steel trays.
Work Schedule
Work schedule operates on a rotating shift, 7 days a week, that may include 8-hour rotating shifts (day, afternoon, and night) or 12-hour rotating shifts (day or night), based on business and operational requirements. The role may also require extended hours, including evenings and weekends, depending on project deadlines and operational needs.
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.
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.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.