Project Engineer/Senior Specialist, Project Engineering (Biopharmaceutical Manufacturing)

Location: Mississauga, Ontario, Canada

Salary: CAD 75,000–112,500 per year

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for pharmaceutical production.

What you will do

• Lead complex engineering projects, coordinating project, design, construction, production, client, and supplier stakeholders.
• Define requirements and specifications for biopharmaceutical manufacturing equipment, including aseptic fill/finish systems, bioreactors, chromatography, and filtration.
• Support clean utility, cleanroom, HVAC, GMP material-flow, and personnel-flow design.
• Lead commissioning activities, including FAT/SAT execution, punch-list resolution, safety reviews, system turnover, and IQ/OQ support.
• Support manufacturing start-up, troubleshooting, process validation, scale-up, and continuous improvement.
• Act as an engineering subject-matter expert during audits and inspections while mentoring junior engineers and coordinating cross-functional technical work.

Requirements

• Working knowledge of cGMPs and FDA, EMA, and Health Canada regulatory frameworks.
• Experience with facilities and equipment design in a GMP environment, including cleanrooms and HVAC systems.
• Ability to independently lead and coordinate cross-functional project activities with minimal guidance.
• Strong organizational, communication, technical writing, and technical mentorship skills.
• 5+ years of experience in biopharmaceutical manufacturing, process engineering, or a related technical role.
• Ability to travel domestically and internationally for FATs, supplier visits, and client-site activities; work may involve cleanrooms, PPE, extended standing, lifting up to 50 lbs, and respirator use.

Nice to have

• Bachelor’s degree in Chemical, Mechanical, Biomedical, or related Engineering, or equivalent experience.
• Professional Engineering (P.Eng) designation.
• Experience with capital projects, commissioning, qualification, risk assessment, ASME BPE, ISPE Guidelines, and global regulatory bodies including PMDA.
• Experience with aseptic processing, vial filling, and lyophilization.

Culture & Benefits

• Typical working hours are 8:00 a.m.–4:30 p.m. or 9:00 a.m.–5:00 p.m., depending on business needs.
• Annual cash bonus program and RRSP/DPSP with company match.
• Healthcare, dental, vision, life, long-term disability, and accidental death and dismemberment benefits.
• Paid vacation, paid holidays, pregnancy and parental leave top-up, fertility and family-forming benefits.
• Tuition reimbursement and employee referral program.

Hiring process

• Accommodation requests can be made at any stage of the recruitment process.
• Recruiter conversation is part of the application process.