Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: ASAP
End Date: 31.12.2026
We are looking for a proactive Validation Specialist to join our site and lead our Cleaning Validation activities in a dynamic biotech environment. In this role, you will be a key player in ensuring our manufacturing processes remain compliant and efficient.
Your Mission:
- Coordinate cleaning validation and verification activities in strict adherence to the site Validation Master Plan (VMP).
- Define cleaning validation strategies, including risk assessments, change-over protocols, and change controls for new and existing processes.
- Draft technical plans, protocols, and reports (in English and French) focusing on cleaning efficacy and regulatory compliance.
- Analyze critical parameters related to automated systems to troubleshoot cleaning validation issues and ensure process robustness.
- Address microbiological challenges within cleaning cycles, specifically regarding bioburden and endotoxin control in a biotech environment.
- Synchronize sampling and analytical tasks between manufacturing teams and internal/external laboratories.
- Provide validation expertise during investigations, deviations, and Change Controls to ensure a continuous state of control.
- Maintain "inspection-ready" documentation and present cleaning data during health authority audits and partner inspections.
- Uphold rigorous cGMP standards and ensure all cleaning validation procedures and training remain up-to-date.
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