Vast contract

Contract type


Key Accountabilities:

  • 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.
  • We are looking for a validation engineer who has project experience with validation of software packages and computerized systems.
  • 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 - looking to hire medior/senior profiles
  • Good knowledge English and Dutch
  • A position on a consultancy basis
  • A full-time position in day shift with flexible hours.
  • The opportunity to make a difference in a varied position at a local level within an international and dynamic company focused on people's health and well-being.
  • A stimulating work environment in which you can further develop your talents and where there is room for personal growth.
  • A competitive salary and attractive working conditions.

We, at Sanofi, are there beside people in need, as a health journey partner

  • +100,000 employees, representing 142 nationalities
  • 90 countries where Sanofi is present, providing healthcare solutions in 170 countries
  • 69 manufacturing sites in 32 countries
  • 21 Research and Development sites comprising medicines, clinical research and vaccines