Cleaning Validation Expert

vor 15 Stunden

Aubonne, Schweiz Randstad (Switzerland) Ltd. Vollzeit
Job DetailsFor 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 establish documentation related 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 the 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 experience 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 able to build and maintain strong relationships with multiple groups.
  • Proficient in Risk Assessment/Management with 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 they apply to the pharmaceutical industry.
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