Validation & Quality Engineer — Site Owner (GMP)

Paycom - ATS; Brantford; On-site; CAD 80,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Group RRSP

Parental leave

Paid time off

Disability insurance

Employee assistance program

Job summary

Germiphene Corporation, a Young Innovations company in Brantford, Ontario, is hiring a Quality Engineering Specialist. Reporting to the Quality Manager, you will own validation, calibration and preventive maintenance programs and ensure ongoing compliance with Health Canada GMP and ISO 13485.

You will lead end-to-end validation, risk assessments, protocol drafting, data interpretation and reporting, coordinate with Production, Maintenance, QC, Microbiology and R&D, and drive CAPAs to closure.

Qualifications

• Bachelor’s degree in engineering or related physical science.
• Minimum five years of experience in quality/validation/metrology in regulated manufacturing.
• Experience authoring and closing validation protocols and reports.

Responsibilities

• Own process validation and qualification end to end.
• Lead risk assessments for validation and cleaning.
• Maintain calibration and preventive maintenance programs.
• Coordinate outside metrology services and certifications.
• Monitor validated processes and support product development.

Skills

Process validation

Risk assessment

Protocols drafting

Statistical sampling

Data interpretation

Report writing

Calibration management

Preventive maintenance

Monitored systems

Education

Engineering degree (mechanical/industrial/manufacturing/chemical/biomedical)

Tools

Calibration management system

Computerized maintenance management

Job description

Germiphene Corporation, a Young Innovations company in Brantford, Ontario, is hiring a Quality Engineering Specialist. Reporting to the Quality Manager, you will own validation, calibration and preventive maintenance programs and ensure ongoing compliance with Health Canada GMP and ISO 13485.

You will lead end-to-end validation, risk assessments, protocol drafting, data interpretation and reporting, coordinate with Production, Maintenance, QC, Microbiology and R&D, and drive CAPAs to closure.