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Cleaning Validation Engineer
Cleaning Validation EngineerMichael Page • Vaud, CH
Cleaning Validation Engineer

Cleaning Validation Engineer

Michael Page • Vaud, CH
Vor 30+ Tagen
Stellenbeschreibung
  • Provide expert support on cleaning validation activities (protocols, reports, investigations, strategies).
  • Review and approve validation documentation (URS, protocols, reports, acceptance limits).
  • Advise on best practices and regulatory standards (ISO, FDA, EMA, PIC / S).
  • Support resolution of deviations, CAPA, and compliance issues.
  • Design and deliver a comprehensive training program for internal teams.
  • Develop training materials and supervise practical implementation on-site.
  • Evaluate team competency and ensure full autonomy post-mission.
  • Conduct critical review of existing SOPs, strategies, and historical reports.
  • Identify opportunities for process simplification and standardization, and propose process improvements.
  • Degree in Chemical Engineering, Biotechnology, Pharmacy.
  • Minimum 5 years of experience in cleaning validation within pharma or sterile medical devices.
  • Strong knowledge of GMP, FDA, and EU regulatory frameworks.
  • Expertise in analytical techniques (TOC, HPLC, gravimetry) and risk-based approaches (MACO, PDE).
  • Demonstrated ability to train and coach multidisciplinary teams with pedagogical skills.
  • Skilled in challenging existing practices and proposing pragmatic solutions.
  • Fluent in English, French is an asset.
  • Work on a high-impact project shaping compliance and operational excellence.
  • High-impact expert role in a global organization.
  • Opportunity to lead strategic compliance and training initiatives.
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    Validation Engineer • Vaud, CH

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