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 : www.akkodis.com
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