Cleaning Validation Engineer

Science
2440 GEEL
Project Sourcing of Freelance
Nederlands
Master
40 u/week
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Functieomschrijving

As a cleaning validation engineer, you: 

  • Develop, implement and execute URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
  • Develop, implement and execute validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements
  • Perform validation of systems in scope for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Sanofi Procedures
  • Ensure that the Validated Status of process systems in scope is in compliance with cGMP at all times
  • Ensure projects are supported in conjunction with all required Sanofi and cGMP regulatory standards
  • Keep current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements
  • Provide technical assistance on current US FDA and EU validation requirements
  • Generate validation documentation (protocols/reports) and provides assistance with the execution of protocols for systems in scope using Kneat paperless validation tool
  • Are responsible for the validation documentation through approval and implementation
  • Provide input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate

Profiel

  • Knowledge of  CGMP requirements in a regulated environment
  • Understanding of relevant quality and compliance regulations
  • Capable of troubleshooting validation issues
  • Experience: 2-4 years experience working in a pharmaceutical sector and GMP environment

Important information

  • Experience with the validation of Clean Steam Generator system and Parts washers is an advantage
  • Very good knowledge of English and Dutch

Aanbod

  • A permanent contract with a competitive salary, complemented by a monthly fixed expense allowance, a company car and fuel card or a monthly gross bonus. Additional benefits include €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus.
  • This package is further enhanced with access to Benefits at Work, sport & culture vouchers, and eco vouchers.
  • You’ll also benefit from a varied and dynamic training offering, including both job-specific and cross-functional courses
  • Expect regular feedback and check-ins with your dedicated HR Business Partner
  • Get to know your fellow consultants during our networking events and team-building activities
  • Kickstart your career at USG Professionals with our two-day Bootcamp

Offer as a freelancer: 

  • Streamline your freelance career with the USG EASY app
  • Receive personalized project proposals based on your profile and availability
  • Enjoy transparent follow-up of your invoicing process
  • Manage all your administration in one app

Bedrijfsinfo

Our client is a global biopharmaceutical company focused on human health. Diversity and inclusion is foundational to how they operate and embedded in their Core Values.They achieve the best results by working closely together in an open and approachable atmosphere.

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