Validation Specialist - Serialization, Vision & 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 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