In this position, you will oversee and execute thermal validation activities for critical process and support equipment, ensuring compliance with industry standards and regulatory requirements. You will collaborate closely with cross-functional teams to deliver qualification documentation, manage validation protocols, and support continuous improvement initiatives. Your expertise will be vital in maintaining equipment integrity and operational excellence within a regulated environment.

Start Date: 18/08/2025

Duration: 12 Months

Place of Work: Visp

Key Responsibilities

  • Perform thermal validation of process and support equipment, including autoclaves, SIP systems, refrigerators, and freezers
  • Use and maintain validation software tools such as ValSuite, eVal Pro, data loggers, and wired thermocouples
  • Develop, review, and approve qualification documentation from CAPEX and OPEX phases, ensuring adherence to standards and SOPs
  • Prepare, review, and revise qualification plans and reports
  • Conduct qualification testing and lead activities with external service providers
  • Ensure test scope and execution comply with company standards and regulatory requirements
  • Update GMP risk analyses post-OQ to prepare for PQ activities
  • Manage and document test results, deviations, CAPAs, and investigations accurately in appropriate systems
  • Oversee change control processes for documentation and equipment, ensuring compliance with company policies
  • Author and review commissioning and qualification summary reports, managing approval workflows
  • Participate in on-the-job training to maintain SME status and facilitate team development
  • Lead commissioning, qualification, requalification, and decommissioning of equipment, including periodic reviews
  • Support maintenance, process improvements, and equipment optimization efforts
  • Contribute to internal and external audits by providing necessary documentation and insights

Candidate Profile

  • Extensive experience in thermal validation within a regulated environment, ideally 5-10 years in the pharmaceutical industry
  • Strong knowledge of validation processes, including IQ/OQ/PQ protocols and documentation standards
  • Proven expertise with validation tools such as ValSuite, eVal Pro, data loggers, and thermocouples
  • Excellent technical writing skills and attention to detail for thorough documentation
  • Effective communicator with the ability to collaborate across departments and with external partners
  • Well-organized with strong time management skills and the ability to handle multiple priorities
  • Knowledge of GMP, cGMP, and relevant regulatory frameworks
  • Languages: Fluent in English and German, both written and spoken

 

 

 

 

 

Job ID 41181036