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