Computer Systems Validation (CSV) Engineer
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
- Develop, implement and execute validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP, User, and Regulatory requirements
- Perform validation of systems in accordance with cGMP and cGLP’s
- Ensure that the Validated Status of computerized systems is in compliance with cGMP at all times
- Provide technical assistance on current US FDA and EU validation requirements
- Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized systems
- Responsible for the validation documentation through approval and implementation
- Provide input in review/assessment of changes
- Conduct statistical analysis of validation data & testing results
- Investigate/troubleshoot validation problems
- Develop protocols to ensure quality standards
- Project experience with rolling out software packages
- Carry out Data migration activities and related tests - current procedures adapted and re-written
- Towards the end of the project, carry out training of new application
- Project management - able to execute projects to plan
- Validation tests
- Data migration
- Writing and adjusting procedures
- Delivering training
- Competent knowledge of Computer Systems Validation
- Full understanding of relevant quality and compliance regulations
- Capable of troubleshooting validation issues associated with projects, e.g. process development
- Pharmaceutical sector experience and GMP environment
- Good knowledge of English and Dutch Language
- Computerized systems / digital tools (e.g. BioLIMS Laboratory Execution System, Electronic flows)
- Agile methodology knowledge
Please apply today for further information!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
Our global bio-pharmaceutical client is seeking the expertise of a Validation Engineer to support their state-of-the-art facility in Belgium. This role requires English and Dutch languages. It will be
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