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.

Tasks & responsibilities:

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.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!