Validation Specialist - Middleware Solutions

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.

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