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
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