Resilience

Project Engineer/Senior Specialist, Project Engineering

CAN - ON - Mississauga - Meadowpine Blvd · Senior

Sponsorship not specified$75k-$113kDetected 29 days ago

ComplianceAccessibilityStakeholder ManagementProcess ImprovementCustomer SupportGMPFDA RegulatoryLeadershipCommunicationCollaborationMentoringWriting

About the role

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.
Work Schedule Typical work hours are 8:00 a.m. to 4:30 p.m. or 9:00 a.m. to 5:00 p.m., depending on business needs.

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.
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.
Collaborate with cross-functional teams including Quality, Validation, Maintenance, and Operations to support site and project objectives.

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 provide technical mentorship and knowledge to transfer to junior engineers and peers

Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field), or equivalent experience
an advanced degree is an asset.
5+ years of experience in biopharmaceutical manufacturing, process engineering, or a related technical role.
Professional Engineering (P.Eng) designation.
Demonstrated expertise in capital projects, commissioning, qualification, and troubleshooting within a regulated environment.
Proficiency in risk assessment methodologies, project execution, and continuous improvement initiatives.
Experience in fill-finish processes, including aseptic processing, vial filling, and lyophilization.
Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.

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, fert

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.

This listing is sourced directly from Resilience's careers page and normalized into a canonical job model.