Cleaning Validation Expert -DS (all genders).

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For our client Merck in Aubonne, we are looking for a Cleaning Validation Expert (m/f/d) for a period of 12 months.
 

Your Role :
 
  • Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment
  • Establish and execute validation protocols and reports for cleaning validation
  • Ensure reliability and conformity of validation and control activities in line with internal and regulatory procedures and guidelines
  • Provide technical support to cleaning activities associated with the manufacturing process.
  • Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises (Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results)
  • Support the periodic process review and etablish documentation relation to control of the process  (PCS, sampling plans and commercial panel testing )
  • Lead the enhancement of cleaning practices
  • Share best practices and train teams
  • Be cleaning Expert during audits and inspections
 
Who You Are:
  • Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
  • Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
  • Fluent in english and french
  • Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
  • Proficient time management skills, planning and organization capabilities.
  • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
  • Proficient in Risk Assessment/Management Proven assessment, analytical and problem-solving skills.
  • Proficient presentation skills and Technical Writing/Oral communication skills (English) Proficient in cGMP's, and FDA Regulations as it applies to pharmaceutical industry.
For our client Merck in Aubonne, we are looking for a Cleaning Validation Expert (m/f/d) for a period of 12 months.
 

Your Role :
 
  • Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment
  • Establish and execute validation protocols and reports for cleaning validation
  • Ensure reliability and conformity of validation and control activities in line with internal and regulatory procedures and guidelines
  • Provide technical support to cleaning activities associated with the manufacturing process.
  • Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises (Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results)
  • Support the periodic process review and etablish documentation relation to control of the process  (PCS, sampling plans and commercial panel testing )
  • Lead the enhancement of cleaning practices
  • Share best practices and train teams
  • Be cleaning Expert during audits and inspections
 
Who You Are:
  • Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
  • Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
  • Fluent in english and french
  • Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
  • Proficient time management skills, planning and organization capabilities.
  • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
  • Proficient in Risk Assessment/Management Proven assessment, analytical and problem-solving skills.
  • Proficient presentation skills and Technical Writing/Oral communication skills (English) Proficient in cGMP's, and FDA Regulations as it applies to pharmaceutical industry.

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KK

Kata Kulcsár

  • Lausanne Professionals Life Sciences

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