Qualification & Cleaning/Sterilization Validation SME (Subject Matter Expert)

We are looking for a Qualification & Cleaning/Sterilization Validation Subject Matter Expert (SME) to join our Technology Lifecycle Excellence (TLE) team.

In this role, you will lead and supervise qualification and validation activities across the site, ensuring systems, processes, and documentation meet the highest quality and regulatory standards, while maintaining a state of continuous inspection readiness.

This is a strategic, high-impact role requiring strong technical expertise, leadership, and cross-functional collaboration in a dynamic pharmaceutical environment.

Responsibilities

Project Leadership & Execution

• Lead and supervise site projects related to:
  • Equipment Qualification
  • Computer System Validation (CSV)
  • Cleaning & Sterilization Validation
• Coordinate with cross-functional teams and global stakeholders to implement best practices and ensure compliance.
• Define, plan, and execute validation strategies while ensuring timely project delivery.

Documentation & Compliance

• Develop, review, and improve qualification and validation documentation, including:
  • SOPs
  • Protocols and reports
• Ensure all validation activities meet GMP regulations and internal quality standards.
• Deliver compliance and technical documentation aligned with regulatory expectations.

SME & Site Representation

• Serve as the site SME for Qualification and Cleaning/Sterilization Validation.
• Represent TLE in:
  • Local site meetings
  • Global cross-functional forums
• Support regulatory inspections and act as a key contact for validation-related topics.
• Provide expert guidance and direction aligned with TLE leadership.

Continuous Improvement & Innovation

• Lead root cause investigations and support deviation and change management.
• Evaluate new equipment and technologies from a validation standpoint.
• Harmonize and streamline validation practices across the site to improve efficiency and compliance.
• Drive simplification and innovation initiatives.

Requirements:

• Bachelor’s or Master’s degree in Engineering, Biotechnology, Biology, Microbiology, or a related field
• Minimum 5 years of experience in a pharmaceutical or regulated environment, including:
• At least 2 years of hands-on experience in:
  • Computer System Validation (CSV)
  • Equipment Qualification
  • Cleaning & Sterilization Validation
• Strong knowledge of GMP regulations, industry standards, and regulatory expectations
• Proven experience in auditing, inspections, and compliance within the pharmaceutical industry
• Solid experience in Change Control and Deviation Management processes
• Strong project management skills, with the ability to prioritize, plan, and deliver projects on time
• Ability to lead cross-functional projects and drive implementation, improvement, or remediation initiatives
• Excellent communication and stakeholder management skills, with the ability to clearly present complex topics
• Demonstrated ability to work collaboratively in a global, cross-functional environment
• Strong problem-solving skills and experience with root cause investigations
• Ability to drive process improvements, standardization, and simplification initiatives

Additional information:

• Contract duration: 01/07/2026 to 30/11/2027
• Location: Schachen LU
• Home Office: Yes, hybrid
• Temporary contract with an option for extension
• Attractive salary and benefits

Verschlagwortet als: Qualification & Cleaning, Sterilization Validation SME