Specialist II, Validation (Biomanufacturing)

Location: CAN - ON - Mississauga - Meadowpine Blvd; onsite role

Salary: CAD 70,000–96,250 per year

Company

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

What you will do

• Perform impact assessments and execute commissioning, qualification, and validation activities for equipment, utilities, facilities, computerized systems, processes, and cleaning systems.
• Prepare validation protocols and reports, compile validation data, and assess results against acceptance criteria.
• Support FAT, commissioning, and SAT activities for new equipment and new or renovated facilities.
• Troubleshoot equipment and process issues and implement corrective solutions.
• Manage deviations, change requests, CAPAs, and validation improvements through closure.
• Coordinate scope, schedules, budgets, risks, and status updates across Engineering, Quality, Maintenance, Operations, design, construction, and external consultants.

Requirements

• Working knowledge of cGMPs, biopharmaceutical guidelines, and FDA and Health Canada regulatory frameworks.
• Experience executing IQ/OQ/PQ validation protocols and preparing summary reports.
• Knowledge of 21 CFR Part 11, EU GMP Annex 1, Annex 11, Annex 15, and computerized system validation requirements.
• Experience with deviations, CAPAs, change control, root-cause investigation, and quality-system records.
• Strong organizational, presentation, technical writing, data analysis, and collaboration skills.
• Ability to work independently with minimal guidance and perform basic statistical analysis of validation data.

Nice to have

• Bachelor's degree in engineering or science; a Master's degree is preferred.
• 2+ years of direct validation or Process/Product Engineering Compliance experience in a biopharmaceutical environment.
• Experience with aseptic manufacturing, aseptic process simulation, sterilization, temperature mapping, process validation, computerized system validation, or cleaning validation.
• Experience with risk and impact assessments, electronic quality management systems, and Microsoft Word, Excel, or Visio.

Culture & Benefits

• Full-time employment with an annual cash bonus program.
• RRSP/DPSP with company matching and healthcare, dental, vision, life, LTD, and AD&D benefits.
• Fertility and family-forming benefits, paid vacation, paid holidays, and pregnancy and parental leave top-up.
• Tuition reimbursement and employee referral program.
• Work may include extended hours, evenings, and weekends based on project and operational needs.
• Physical work may involve extended standing, crouching or squatting, and lifting up to 10 kg.