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GeoTraceability by OPTEL

Validation Specialist – Middleware Solutions

Greater Montreal Metropolitan Area, QC, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Oct 17, 2026
Experience: Minimum of 2 years of experience in system testing and validation or in technical writing.
Posting language: English
Posted: Aug 21, 2026

Original job description

OPTEL is one of the world’s leading providers of traceability systems. Its mission is to leverage innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of healthcare products and help fight the counterfeiting of medicines and medical devices worldwide. OPTEL also adapts its technologies to a variety of sectors, from healthcare to smart manufacturing and beyond, enabling all industries to benefit from global traceability. OPTEL’s expertise empowers industries to measure, inspect, control, and track a wide range of elements in order to improve product quality and promote a more responsible use of resources.

Summary

The Validation Specialist is responsible for creating and maintaining validation documents, such as internal validation protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Change Controls, to ensure that Optel systems comply with industry standards. This role requires expertise in documentation, a drive for innovation through continuous improvement, and the ability to collaborate with internal teams and clients to ensure project validation and quality control.

Tasks

Validation documentation and management:

Manage the validation template lifecycle: maintain, optimize, and automate existing templates (using MS Office Suite and VBA macros) to increase efficiency while ensuring regulatory compliance, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11.
Identify and implement continuous improvement opportunities, including leveraging Artificial Intelligence tools to streamline document drafting and review processes.
Review and understand system updates, including new releases and hotfixes, to determine the impact on validation documents.
Generate validation documents for clients based on the functional and design specifications of the projects.
Execute internal validation protocols as needed to ensure system functionality.

Risk Analysis And Quality Improvement

Identify potential risks associated with validation activities and develop mitigation strategies.
Lead root cause investigations for validation discrepancies and implement corrective actions for continuous quality improvement.

Collaboration And Expertise

Partner with various internal departments to deliver validation documentation at specific stages of project development.
Collaborate closely with the internal team and clients to provide expert guidance on validation strategies and best practices.
Work closely with the quality assurance (QA) team to ensure that validation activities are in line with internal quality systems and external regulatory requirements by participating in internal and external audits.
Perform any other tasks related to validation processes

Requisite Skills

College diploma in a relevant field.
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 (World).
Knowledge of macros (Visual Basic / VBA) in Word and Excel is considered an asset.
Strong interest and aptitude for adopting new technologies, including the practical application of Artificial Intelligence for task optimization.
Rigor, analytical skills, and attention to detail.
Ability to collaborate effectively within a team and communicate with stakeholders at all levels.
Strong curiosity and a willingness to learn and adopt new technologies, especially artificial intelligence.

Benefits

Competitive compensation
Flexible working hours
Employee Assistance Program (EAP)
Comprehensive group insurance plan
A global organization with a presence on several continents

OPTEL is an equal opportunity employer. We believe that diversity is essential to fostering innovation and creativity. We welcome and encourage applications from individuals of all backgrounds, cultures, gender identities, sexual orientations, abilities, ages, and beliefs. We are committed to providing a fair and inclusive recruitment process in which every candidate is evaluated solely on their qualifications, skills, and potential. At OPTEL, each employee’s unique perspective contributes to our collective success, and we celebrate the richness that diversity brings to our tea

See the offer on Jazzhr

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More about this job

Responsibilities

Create, maintain, and improve validation templates and client documentation, including IQ, OQ, and change controls, while ensuring compliance with applicable regulatory standards. Assess system updates, execute validation protocols, investigate discrepancies, and collaborate with internal teams and clients on validation strategies and quality activities.

Requirements

A college diploma in a relevant field and at least two years of experience in system testing and validation or technical writing are required. Candidates need excellent written and spoken English, advanced Microsoft Office skills, strong analytical attention to detail, and the ability to collaborate; VBA knowledge and interest in applying AI are assets.

Skills

Validation Documentation
System Testing
Technical Writing
Microsoft Office
VBA Macros
Risk Analysis
Root Cause Analysis
Corrective Actions
Regulatory Compliance
GAMP
FDA 21 CFR Part 11
EU Annex 11
Quality Assurance
Audit Participation
Artificial Intelligence
Stakeholder Collaboration

Benefits

Flexible Working Hours
Employee Assistance Program

Visa sponsorship

Not detected in the job text

Keywords

Traceability Systems
Validation
Validation Protocols
Installation Qualification
Operational Qualification
Change Controls
Validation Templates
Microsoft Office
VBA
Visual Basic
GAMP
FDA 21 CFR Part 11
EU Annex 11
Artificial Intelligence
System Updates
Hotfixes
Functional Specifications
Design Specifications
Risk Mitigation
Root Cause Investigations
Corrective Actions
Continuous Improvement
Quality Assurance
Internal Audits
External Audits
Regulatory Compliance
Healthcare
Pharmaceuticals
Medical Devices

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