Validation Specialist: Serialization & Automated Inspection Systems

Optel Group; Quebec; On-site; CAD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Flexible working hours

Employee Assistance Program (EAP)

Comprehensive group insurance

Job summary

OPTEL is seeking a Validation Specialist to create, update, and maintain validation documentation for packaging inspection serialization systems, including IQ, OQ, and change controls. The role ensures compliance with GMP, FDA 21 CFR Part 11, and EU Annex 11 while delivering high-quality documentation for projects.

You will collaborate with internal teams and clients, analyze risks, drive quality improvements, and support successful project delivery in regulated environments.

Qualifications

• Minimum of 2 years of experience in system testing and validation or in technical writing.
• Excellent proficiency in English (written and spoken).
• Advanced knowledge of the Microsoft Office suite (Word/Excel).
• Knowledge of macros (Visual Basic / VBA) in Word and Excel is considered an asset.

Responsibilities

• Develop and maintain validation templates for internal use and client projects in line with GMP, FDA 21 CFR Part 11, and EU Annex 11.
• Review system updates to determine impact on validation documents.
• Generate validation documents based on project specifications and perform internal validation as needed.
• Coordinate with internal departments and clients to deliver validation documentation at project milestones.

Skills

English proficiency

Analytical skills

Attention to detail

Team collaboration

Willingness to learn

AI interest

Education

College diploma

Tools

Microsoft Office

VBA macros

Job description

OPTEL is seeking a Validation Specialist to create, update, and maintain validation documentation for packaging inspection serialization systems, including IQ, OQ, and change controls. The role ensures compliance with GMP, FDA 21 CFR Part 11, and EU Annex 11 while delivering high-quality documentation for projects.

You will collaborate with internal teams and clients, analyze risks, drive quality improvements, and support successful project delivery in regulated environments.