CSV Engineer

Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.

Akkodis is part of the Adecco Group. Our Website :

Key Responsibilities:

• Validation Protocol Development: Design, develop, and execute validation protocols (IQ, OQ, PQ) for software applications, hardware, and systems to ensure compliance with regulatory standards.
• Cross-Functional Collaboration: Work closely with IT, Quality Assurance, and other departments to ensure that all systems are validated and compliant with industry regulations and internal policies.
• Risk Assessment: Conduct thorough risk assessments to identify potential compliance issues and develop mitigation strategies to address them.
• Documentation Management: Maintain comprehensive documentation throughout the validation lifecycle, including validation plans, test scripts, and final reports, ensuring traceability and compliance with GxP standards.
• Change Control Management: Participate in change control processes to assess the impact of changes on validated systems and ensure that appropriate re-validation is performed.
• Training and Support: Provide training and support to team members on validation processes and best practices, fostering a culture of quality and compliance within the organization.
• Continuous Improvement: Identify opportunities for process improvements and contribute to the development of best practices in validation and compliance.

Qualifications:

• Bachelor or Master's degree in Engineering, pharmaceutical science, or a related field.
• Proven experience in Computer System Validation (CSV) within the life sciences industry, with a strong understanding of regulatory requirements (FDA, GxP, ISO).
• Familiarity with validation tools and methodologies, as well as experience with electronic systems and software applications.
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Strong communication skills, both written and verbal, with the ability to work collaboratively in a fast-paced environment.
• Ability to manage multiple projects and priorities effectively.

What’s the offer you can’t refuse?

As an AKKODIS Team member, you will be:

• Onboarded in your position via a buddy process
• Supported in your career by your Business Manager
• Actor of your training plan and your personal and professional development
• Benefiting from a permanent contract
• Benefiting from a competitive salary package including several extra-legal benefits