Jobdescription
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.
Qualifikationen
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.
#J-18808-Ljbffr