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Randstad Logo Randstad · IT - Administration

Qualification and Cleaning/Sterilization Validation Subject Matter Expert

Switzerland, Schachen, Luzern · Job Posted June 01, 2026
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Job Description

For one of our clients, an international pharmaceutical company, we are seeking a Qualification and Cleaning/Sterilization Validation Subject Matter Expert. General Information: Start date: 01.07.2026 End Date: 30.11.2027 Workplace: Schachen, Luzern Home office: No, 100% onsite Workload: 100% Working hours: Standard About the work: The Qualification and Cleaning/Sterilization Validation Subject Matter Expert (SME) is a role within the Technology Lifecycle Excellence (TLE) team. This function leads/supervises Qualification and Cleaning/Sterilization Validation projects. It is the responsibility of this function to implement new systems and processes to a state of permanent inspection readiness. The person ensures the success of the unit by maintaining a strategic focus and a high customer service level, fostering a high-performance organization, and effectively collaborating across the organization. The position ensures a culture of self-direction, empowerment, and accountability, while providing the support necessary to team members working in a widely cross-functional organization.

Job Responsibility

  • Lead/Supervision of site projects related to Qualification, CSV, Cleaning/Sterilization Validation
  • Lead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations
  • Responsible for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports
  • Responsible for compliance deliverables and technical deliverables related to qualification and validation
  • Act as an SME and point of contact for Qualification and Cleaning/Sterilization Validation at the entire Site
  • Represent TLE at both local site meetings and cross functional global meetings
  • Represent Qualification and Cleaning/Sterilization Validation aspects during inspections
  • Provide direction, give guidance and implement procedures in agreement with TLE Lead
  • Responsible for the area’s implementation of process changes, and root cause investigation of deviations
  • Responsible for the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements
  • Identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort

Requirements

  • University degree preferable in Engineering, Biotechnology, Biology, Microbiology
  • Minimum 5 years of experience in pharmaceutical environment with minimum 2 years of experience in computer system validation, equipment qualification and cleaning validation
  • Excellent know-how of current GMP regulations and industrial standards
  • Extensive experience in Auditing and Compliance within the pharmaceutical industry
  • Change and Deviation Management experience
  • Strong Project Management skills: organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines, and ensuring on-time delivery. Can define and lead projects to support improvement, implementation or remediation
  • Strong communication skills: Plans and delivers ideas and information to others in a clear and impactful manner
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