Validation Engineer

For one of our clients in the pharmaceutical industry, we are looking for a medior/senior Computer System Engineer (CSV).

The CSV role is Computer System Validation, focused on quality and computer/automation or technical basic knowledge of the systems.

About Akkodis

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 Webstite :

Main responsibilities

• Ensure the execution of the pre-tests before starting the final implementation of the new processes
• Coordinate all GMP documentation necessary for change control management (VP - TCD - VSR - QAGMP authorization - QAGMP approval - external contingent documentation, etc.)
• Drafting of URS, FAT, SAT, IQ, OQ, PQ validation protocols and analysing the results during PQ passages.
• Ensure the planning of validations in partnership with the C&M/QA departments and production
• Ensure communication with the production team
• Ad hoc assemblies/resources for validation
• Ensure the operational management of technicians dedicated to validations
• Ensure all deviations related to the implementation of the change
• Track QC results for each validation cycle
• Ensure timely collection/transfer of approved local documents to RA department to ensure timely submission of case
• Ensure the review of the preparation of the file in partnership with the QA before the submission of the file of the authorities.

Researched profile

• Degree in engineering or scientific bachelor (bio engineer, electronics, computing, automation, industrial engineer, IT, )
• Minimum 3 years of experience in Computer System Validation (CSV)
• 2 years experience on pharmaceutical industry
• Proficiency in English AND French is required
• Good communication skills (close interaction with stakeholders)
• Problem-solving skills
• Motivation to provide result on time
• Determines how to move the project forward
• Analytica thinking, requests and execution, problems, project plan, timelines,
• Interact closely with the stakeholders, coordination
• Good communicator between stakeholders
• Readiness to demonstrate a proactive attitude
• Good verbal and written communication skills

Why join Akkodis?

By joining the AKKODIS team, you will benefit from:

A personalized onboarding process through a mentoring system Career support from your Business Manager Active involvement in your training plan as well as in your personal and professional development A permanent contract A competitive salary package, including several extra-legal benefits