Own validation and qualification programs as a Quality Engineering Specialist in Brantford, Ontario, using risk assessment and statistical sampling expertise.

Germiphene Corporation, a Young Innovations company, seeks a Quality Engineering Specialist reporting to the Quality Manager. You will maintain continuous compliance with Health Canada GMP, ISO 13485, and regulatory requirements. The position covers process validation, equipment qualification, calibration, preventive maintenance, and monitored systems. You will coordinate with Production, Packaging, Maintenance, Quality Control, Microbiology, R&D;, and Regulatory Affairs.

Key Responsibilities:

- Develop validation protocols, acceptance criteria, sampling plans, and approved reports
- Lead process, equipment, cleaning validation, and FMEA risk assessments
- Own equipment qualification, calibration, and preventive maintenance programs




- Monitor purified water, temperature, and humidity systems
- Manage change controls, CAPAs, documentation, training, and audits

Requirements:

- Bachelor’s degree in engineering, chemistry, or related physical science
- Minimum five years’ regulated manufacturing quality, validation, or metrology experience
- Two years owning validation, calibration, or preventive maintenance programs
- Experience authoring protocols, reports, and statistical sampling plans
- Working knowledge of Health Canada GMP and ISO 13485

Apply quality engineering expertise in validation, qualification, and statistical analysis across Germiphene’s Brantford manufacturing site.

📌 Quality Validation Engineering Specialist (Brantford)
🏢 Young Innovations
📍 Brantford