Jobdescription
For ourclient Merck in Aubonne, we are looking for a Cleaning ValidationExpert (m/f/d) for a period of 12 months.
Your Role :
* Coordinate cleaning validation andmonitoring activities in line with the life cycle of amanufacturing process for biotech manufacturingequipment
* Establish and execute validationprotocols and reports for cleaningvalidation
* Ensure reliability and conformity ofvalidation and control activities in line with internal andregulatory procedures and guidelines
* Providetechnical support to cleaning activities associated with themanufacturing process.
* Perform successful andon time resolution of incidents and deviations related to cleaningvalidation exercises (Investigates and conductstroubleshooting/root cause analysis of cleaning related incidents,deviations and cleaning out of specificationresults)
* Support the periodic process reviewand etablish documentation relation to control of the process (PCS, sampling plans and commercial panel testing)
* Lead the enhancement of cleaningpractices
* Share best practices and trainteams
* Be cleaning Expert during audits andinspections
Who YouAre:
* Bachelor's or Master's Degree in Science,Pharmacy or Engineering.
* Minimum of 5 years ofprofessional experiences in cleaning validation in thepharmaceutical and biotechnologyindustries.
* Fluent in english andfrench
* Proficient knowledge of cleaningvalidation, continuous process improvement and troubleshootingprocesses.
* Proficient time management skills,planning and organization capabilities.
* Provenleadership & teamwork skills, self starter, results orientedand build and maintain strong relationships with multiplegroups.
* Proficient in RiskAssessment/Management Proven assessment, analytical andproblem-solving skills.
* Proficient presentationskills and Technical Writing/Oral communication skills (English)Proficient in cGMP's, and FDA Regulations as it applies topharmaceutical industry.