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Optel Group

Validation Specialist - Serialization, Vision & Automated Inspection Systems

Quebec, QC, G1P 4S6, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Jan 7, 2027
Experience: Minimum of 2 years of experience in system testing and validation or in technical writing.
Posting language: English
Posted: Oct 9, 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, updating, and maintaining the validation documentation required for OPTEL systems, including internal test protocols, Installation Qualifications (IQ), Operational Qualifications (OQ), and change controls. They help ensure that packaging inspection serialization systems (L1–L2) meet pharmaceutical industry requirements, as well as expected standards of quality, compliance, and reliability. This role requires strong attention to detail in documentation, a solid understanding of regulated environments, and the ability to collaborate effectively with internal teams and clients to support successful project delivery.

Tasks:

Validation documentation and management:

Develop and maintain standardized validation templates for internal use and for clients that comply with industry standards and regulatory guidelines, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11, V-Cycle.
Review and interpret 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 and compliance.

Risk Analysis and Quality Improvement:

Actively participate in risk analyses to identify potential risks associated with validation activities and develop mitigation strategies.
Identify root causes following validation non-conformities and implement corrective actions for continuous quality improvement.

Collaboration and Expertise:

Coordonate 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

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More about this job

Responsibilities

The Validation Specialist is responsible for creating and maintaining validation documentation such as IQ, OQ, and test protocols for serialization and inspection systems. They also collaborate with internal teams and clients to ensure compliance with regulatory standards and perform risk analyses to support quality improvement.

Requirements

Candidates must hold a college diploma in a relevant field and possess at least 2 years of experience in system testing, validation, or technical writing. Proficiency in English, advanced Microsoft Office skills, and a strong aptitude for learning new technologies are required.

Skills

Validation documentation
System testing
Technical writing
GAMP
FDA 21 CFR Part 11
EU Annex 11
V-Cycle
Risk analysis
Quality assurance
Microsoft Office
Visual Basic
VBA
Artificial intelligence
Analytical skills
Attention to detail
Communication

Benefits

Competitive compensation
Flexible working hours
Employee Assistance Program

Visa sponsorship

Not detected in the job text

Keywords

Validation
Serialization
Vision systems
Automated inspection
Traceability
GAMP
FDA 21 CFR Part 11
EU Annex 11
V-Cycle
IQ
OQ
Quality assurance
Risk analysis
Technical writing
Microsoft Office
VBA
Artificial intelligence
Pharmaceutical industry
Compliance
System testing
Change control
Manufacturing
Healthcare
Documentation

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