CSV Engineer
CSV Engineer
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Job Description
General information
Publication date
21/05/2025Category
OPERATIONS - CONSULTING
Job title
CSV Engineer
Contract
Permanent contract
Job description
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 50000 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.
Business Industry
Life sciences
Profile
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
Job location
Europe Belgium Wallonia
Location
Candidate criteria
Level of experience
3 to 5 years
Employment Type
Full-Time
