Responsibilities
* Generating and reviewing of periodic Asset documentation including audit trails, Asset Folders, and User Access levels
* Maintaining access control for manufacturing and ensuring trained personnel and host access to support Validation / Engineering activities
* Supporting in progressing of Validation Lifecycle documents and activities for assets (URS, DQ, RQ, VRR's, CST etc)
* Generating and updating of asset documentation e.g. equipment logbooks, SOPs
* Providing technical support and point of contact for queries / data from internal departments e.g. Validation and support QMS, and Audits and Client requests
* Liaising with Equipment & Systems vendors to resolve any technical issues that are identified
* Executing NPI actions which relate to equipment introduction or modification
* Supporting the implementation and review of HAZOPs
* Acting as the subject matter expert where required for QMS and supporting/taking ownership of QMS records for equipment and Systems
Qualifications
* A-Level, preferably science based with previous industrial experience
* Graduate in STEM subject (preferred)
* Experience working in a GMP environment
* Experience working with Cell & Gene therapy manufacturing equipment and systems, e.g. bioreactors, chromatography, clean rooms etc.
* Ability to travel across all Oxfordshire sites
* Willingness to working within Cleanroom environment when required
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