Project Engineer​/Senior Specialist, Project Engineering

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.

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The Project Engineer/Senior Specialist, Project Engineering leads the execution of complex engineering projects in a GMP biopharmaceutical environment, exercising independent technical judgment with minimal supervision. Acting as a technical advisor across the project and production teams, the role drives equipment implementation, commissioning and qualification, and production support, while coaching junior engineers and building cross-functional alignment on technical issues.

• Lead the execution of complex technical projects, coordinating internal and external stakeholders to ensure alignment, efficiency, and regulatory compliance.
• Support client and stakeholder engagement on project deliverables, providing technical input and responding to queries in coordination with the project manager.
• Coordinate design, construction, and internal teams to execute capital and client projects.
• Track project scope, schedule, and budget for assigned engineering projects; elevate risks and issues to the Engineering Manager in a timely manner.
• Prepare and present project status updates to the Engineering Manager and cross-functional stakeholders.

• Define specifications for in-scope systems and equipment, including user requirement specifications (URS).
• Design and specify equipment for biopharmaceutical manufacturing, including aseptic Fill/Finish operations, bioreactors, chromatography systems, and filtration.
• Support the design and operation of clean utilities, including purified water (PW), water for injection (WFI), compressed air, and clean steam.
• Apply cleanroom design, grade classifications, GMP material/personnel flows, and HVAC design principles to project deliverables.
• Review bids, design documents, quotations, and functional specifications against project requirements, technical specifications, and budget.
• Manage engineering change control for assigned systems; ensure drawings, specifications, and documentation are maintained accurately and in a state of audit readiness.
• Conduct risk assessments (e.g. FMEA, HAZOP) to identify and mitigate technical and compliance risks during design and implementation phases.

• Assess process systems and components for compliance with FDA, EMA, HC, and cGMP requirements, including applicable guidelines such as EU GMP Annex 1 and ISPE Baseline Guides.
• Ensure systems meet Environmental Health and Safety (EHS) and regulatory requirements.
• Lead commissioning activities including FAT/SAT execution, punch list resolution, Pre-Start Health and Safety Reviews (PSHSR), and system turnover to end user.
• Provide engineering input and documentation to support IQ/OQ protocol development and execution in collaboration with the Validation team.
• Investigate and resolve deviations from user and system specifications, implementing corrective actions.
• Support manufacturing start-up, including engineering trials, troubleshooting, and technical support to process validation activities.
• Serve as engineering SME during regulatory inspections and internal audits for assigned systems and projects; contribute to inspection readiness activities and responses to observations.

• Provide technical mentorship to junior engineers and peers, fostering knowledge and capability development within the FME team.
• Collaborate with cross-functional teams including Quality, Validation, Maintenance, and Operations to support site and project objectives.
• Troubleshoot equipment and process issues to minimize downtime and optimize performance; lead root cause investigations and implement corrective and preventive actions.
• Implement process improvements to increase production rates, yields, and uptime.
• Prepare technical reports, risk assessments, and protocols on manufacturing systems and processes.
• Support scale-up through process optimization and validation for large-scale production.
• Develop and review SOPs to standardize practices and maintain regulatory compliance.

• Working knowledge of cGMPs and applicable regulatory frameworks (FDA, EMA, Health Canada) in a biopharmaceutical or regulated production environment
• Working knowledge of facilities and equipment design in a GMP environment, including cleanroom layout, HVAC systems, and regulatory compliance
• Experience in a fast-paced, customer-oriented manufacturing or operations environment
• Ability to work independently with minimal guidance in a project environment
• Demonstrated ability to lead and coordinate…