CSV 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 : 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.

Ideal 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
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