Process Engineer

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

Project Responsibilities:

• Develop and define specifications for systems and equipment within the project scope, including drafting comprehensive user requirement specifications (URS). Hands-on experience in equipment design for biopharmaceutical manufacturing, including aseptic Fill/Finish operations, Bioreactors, chromatography systems, and filtration. 
• Experience with utilities design and operation, including purified water systems (PW), water for injection (WFI), compressed air, and clean steam.
• Experience with Clean room design/grades/classifications, GMP Flows and HVAC design principles
• Evaluate and review bids, design documents, quotations, and functional specifications to ensure alignment with project requirements, technical specifications, and budget constraints.
• Assess compliance with regulatory requirements from agencies such as the FDA, EMA, and HC for process systems and components, ensuring adherence to current Good Manufacturing Practices (cGMP).
• Ensure systems meet Environmental Health and Safety (EHS) standards and regulatory requirements, promoting a safe and compliant work environment.
• Coordinate, review, and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate system functionality before deployment.
• Identify, investigate, and resolve deviations from user and system specifications, ensuring corrective actions are effectively implemented.
• Draft and execute commissioning and qualification protocols, including Installation Qualification (IQ), and Operational Qualification (OQ).
• Support manufacturing start-up, including engineering trials, troubleshooting, and process validation activities.
• Assist in engineering runs, ensuring successful transition from commissioning to full-scale manufacturing.
• Act as a key interface with clients to align project deliverables with their expectations and objectives.
• Act as point of contact with design and construction team to execute capital projects and client projects. 

Production/Manufacturing Support:

• Diagnose and troubleshoot equipment and process-related issues to minimize downtime and optimize performance.
• Identify and implement process improvements aimed at enhancing production rates, increasing yields, and improving uptime.
• Prepare and present detailed technical reports on manufacturing systems, processes, and operational efficiencies such as risk assessments and protocols. 
• Support scale-up activities by assisting in process optimization and validation for large-scale production.
• Develop and review SOPs to standardize best practices and maintain compliance with regulatory guidelines.
• Maintain and update engineering drawings under strict change control procedures to ensure accurate documentation of modifications.

Minimum Qualifications:

• Experience in GMP or regulated production environment

• Experience in a manufacturing or operations-based field/industry involving a fast-paced, customer-oriented environment

• Ability to direct self and others in a project environment

• Experience in demonstrating skills in the areas of: asking questions, listening, providing feedback, self-awareness

• Expertise in facilities design, including cleanroom layout, HVAC systems, and GMP compliance.

Preferred Qualifications:

• Master’s degree in Engineering, Biotechnology, or a related discipline or Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field), or equivalent experience.
• 5-7 years of experience in biopharmaceutical manufacturing, process engineering, or a related technical role.
• P.Eng and PMP qualifications 
• Demonstrated expertise in capital projects, commissioning, qualification, and troubleshooting within a regulated environment.
• Experience working with global regulatory bodies (FDA, EMA, HC) and a strong understanding of cGMP requirements.
• Proficiency in risk assessment methodologies, project execution, and continuous improvement initiatives.
• Experience in fill-finish processes, including aseptic processing, vial filling, and lyophilization.

This position may also include the following conditions:

• Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.
• Ability to travel domestically and internationally as required for client engagements, technical transfers, and site support.
• Physical demands may include standing for extended periods, lifting moderate weights, and working in cleanroom environments with appropriate gowning requirements.

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 equity, 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, flexible time off, 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 $75,000.00 - $112,500.00 per year. 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.