Project Engineer/Senior Specialist, Project Engineering
$75,000–$112,500 year
On-siteMississauga, Ontario, Canada
Job Summary
Lead and deliver complex engineering projects in a GMP biopharmaceutical setting, coordinating Design, Construction, and Qualification activities from URS through IQ/OQ, while managing scope, schedule, and budget. Drive equipment selection and commissioning/qualification for aseptic fill/finish, bioreactors, chromatography, and filtration systems; ensure regulatory compliance and audit readiness; mentor junior engineers and align cross-functional teams on technical issues. Partner with Quality, Validation, and Operations to support manufacturing start-up, investigations, and continuous improvement, including risk assessments (FMEA/HAZOP) and inspection readiness. Prepare status updates for leadership and stakeholders, and support regulatory inspections and client interactions.
Required Qualifications
- Working knowledge of cGMPs and applicable regulatory frameworks (FDA, EMA, Health Canada)
- Experience in GMP environment and facilities/equipment design (cleanroom layout, HVAC, etc)
- Ability to work independently with minimal guidance in a project environment
- Demonstrated leadership to coordinate cross-functional project activities
- Strong organizational, communication, and technical writing skills
- Ability to mentor junior engineers and peers
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