We are looking for a Validation Engineer who has project experience with validation of software packages and computerized systems.
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
- Responsible for the validation documentation through approval and implementation.
- Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Sanofi Procedures.
- Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times.
- Ensures projects (moderate scale & complexity) are managed in conjunction with all required Sanofi and cGMP regulatory standards.
- Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
- Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
- Investigates/troubleshoots moderately complex validation problems.
- Strong communication skills
- Capable of working independently and learns fast
- Able to execute project to plan
- Competent knowledge of Computer Systems Validation
- Full understanding of relevant quality and compliance regulations
- Capable of troubleshooting validation issues
- Minimum 3 years experience working in a pharmaceutical sector and GMP environment
- Good knowledge English and Dutch
You will be employed by an external consultancy contract at Sanofi in Geel for a temporarily long assignment.
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