Project Engineer/Senior Specialist, Project Engineering

Resilience • Mississauga, ON

3d • CA$75,000 - CA$112,500 • Onsite

About The Position

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.

Requirements

• 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 cross-functional project activities with and without direct authority
• Strong organizational, communication, and technical writing skills, with the ability to work effectively as part of a high-functioning team
• Demonstrated ability to provide technical mentorship and knowledge to transfer to junior engineers and peers

Nice To Haves

• 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.
• Experience with global regulatory bodies (FDA, EMA, HC, PMDA) and cGMP requirements, including familiarity with engineering standards such as ASME BPE and ISPE Guidelines.
• Proficiency in risk assessment methodologies, project execution, and continuous improvement initiatives.
• Experience in fill-finish processes, including aseptic processing, vial filling, and lyophilization.

Responsibilities

• 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; escalate 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.

Benefits

• annual cash bonus program
• RRSP/DPSP with a generous company match
• 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
• employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior