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