Validation Specialist

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.

Your Profile:

• Master's or Engineering degree in Biotechnology, Pharmacy, or Life Sciences.
• Practical Biotech experience, with solid knowledge of USP, DSP, Buffer, Fill & Finish, and CIP.
• Understanding of microbiological risks, including Bioburden and Endotoxin control in a manufacturing context.
• Excellent technical writing skills in both French and English.
• Proactive communicator, gathering information and collaborating with QA, QC, Maintenance, Logistics, and other internal departments.
• Collaborative team player committed to driving projects forward through active engagement.
• Rigorous and methodical mindset for managing complex validation data and regulatory requirements.