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.

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