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Key skills for this role
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.
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Chicago, USA
Chicago, USA
Mississauga, CAN
Mississauga, CAN
Chicago, USA
, USA
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Chicago, USA
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.
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 Factory Acceptance Testing (FAT) or other technical activities including supplier and client site visits.
Physical demands may include standing for extended periods, lifting up to 50lbs, and working in cleanroom environments with appropriate gowning requirements.
Required to wear Personal Protective Equipment (PPE) including respirators.
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.
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.
Biomanufacturing CDMO serving biopharmaceutical companies with end-to-end manufacturing for complex medicines.
Visit company websiteJobs and hiring trendsCAD 75000-112500 yearly / year
Full-time
Senior
Onsite
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