Project 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**JOB SUMMARY:**The Project Engineer provides advanced engineering support in a GMP biopharmaceutical environment. This role requires strong technical capability, independent leadership, and cross-functional collaboration in the execution of complex projects, equipment implementation, and production support activities.**MAJOR RESPONSIBILITIES:*** Provide leadership in the execution of complex technical projects, coordinating efforts across internal and external stakeholders to ensure alignment, efficiency, and regulatory compliance.* Act as a key interface with clients and stakeholders to align project deliverables with expectations and objectives.* Lead coordination efforts with design, construction, and internal teams to execute capital and client projects.* 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 cleanroom 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.**Production/Manufacturing Support:*** Provide technical mentorship and guidance to junior team members and peers, fostering knowledge sharing and development within the team.* Collaborate with cross-functional teams including quality, validation, maintenance, and operations to support site and project objectives.* 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:*** Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field), or equivalent experience.* 5+ years of experience in biopharmaceutical manufacturing, process engineering, or a related technical role.* P.Eng 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.**ADDITIONAL REQUIREMENTS:*** Pre-employment medical and medical re-examination performed every 2 years or as per Resilience’s SOPs, and may include, as part of the medical, a respirator fit test (half mask), and pulmonary function test.* This position requires vaccination for Hepatitis A and B.* 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**BEHAVIOURAL:** Demonstrated ability to apply the following behavioural competencies on the job:**Teamwork**: Working effectively and productively with others.**Problem Solving**: ability to analyse complex problems and derive root cause.**Organization and Planning**: Utilizing logical, systematic and orderly procedures to meet objectives**Leadership**: Achieving extraordinary business results through people.**Interpersonal Skills**: Effectively communicating, building rapport and relating well to all personality types.**Goal Orientation**: Energetically focusing efforts on meeting a goal, mission or objective.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.#J-18808-Ljbffr