FME Intern

Resilience Biomanufacturing Opportunity

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.

Position Summary

Support engineering services processes in the tech transfer, process design, equipment selection, process set-up and validation, GMP document creation, and operator training for new client and internal projects.

Major Responsibilities

Facilities Management:

• Technical guidance/input on calibration program, CMMS, maintenance, or engineering documentation.
• Support the FME Compliance team by leading the closure of Corrective and Preventive Actions (CAPAs) arising from continuous improvement initiatives and internal/external audit observations.
• Support the Facility and Maintenance department by managing work orders using the CMMS/ERP system.
• Perform physical audits of facility assets to ensure equipment tags and locations match system data.
• Gather necessary technical drawings, safety permits, and documentation packages for maintenance teams.
• Assist in monitoring the work order backlog and support in generating monthly reports on overdue tasks.
• Coordinate with different departments to help track the status of equipment handovers for servicing.
• Prepare and review SOPs and Maintenance, Calibration, and Certification Procedures (MCCPs).
• Performs any other job-related duties as assigned.

Project Responsibilities:

• Conduct technical transfer activities of client and internal processes
• Identify/prepare specifications for systems in project scope and draft user requirement specifications
• Review design documents, quotations and functional specifications against user requirements, specifications and project budget
• Review regulatory requirements (FDA, EMA, HC) for process systems and components against proposed systems
• Review system compliance to Environmental Health and Safety standards and regulations
• Ensure compliance to project quality standards
• Review supplier test specifications and test reports
• Support factory and site acceptance tests
• Identify, investigate and resolve deviations from specifications
• Support Commissioning and IQ, OQ, PQ protocols execution
• Support start-up, and engineering trials
• Support completion of engineering trial lots
• Interface with clients in support of project objectives
• Performs any other job-related duties as assigned

Production / Manufacturing Support:

• Identify and implement process improvements to achieve higher rates, yields and uptime
• Prepare and present technical reports on manufacturing systems and processes
• Support scale-up activities
• Prepare and review SOPs
• Support Engineering drawings control process
• Performs any other job-related duties as assigned

EH&S:

• Support company policy and applicable regulations

Minimum Qualifications

• Student enrolled in an Engineering program in a Canadian University
• Proficient in Microsoft Office (Excel/Word)

Preferred Qualifications

• Sound knowledge of food/pharmaceutical environment
• Sound knowledge of cGMPs and GAMP
• Basic understanding of building systems (HVAC, electrical, or mechanical)
• CAD skills

Additional Requirements

• Regular day shift position, occasional weekends and extended shifts may be required for business support

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.