Requirements: English
Company: Akkodis
Region: Lessines , Walloon Region
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