Job Description
* Execute qualification and validation activities for a life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state.
* Author, review, execution and approval of testing protocols and reports.
Benefits
* Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.
* Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
* Will be flexible to take on additional tasks and responsibilities as requested.
* Will act as a role model for the Validation function and also the wider organization in adherence to the corporate core values.
Experience and Education Required
* A minimum of 3 - 5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function.
* Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
* Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).
* Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
* Experience of equipment vendor package ownership and system design coordination.