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Senior Software Validation Engineer
Preparation, execution, reporting and management of all validation and qualification activities of new and existing equipment, systems and processes relating to the launch of automated test platform,
Determination of Validation Strategy, Validation Studies, Determination of Revalidation Requirements through Risk Assessment,
Interface between Validation and all areas to ensure validation issues are communicated effectively and managed to ensure limited compliance risks, key relationships include but are not limited to: Quality Assurance, Operations, Production, Quality Control and Engineering,
Development, preparation, collation and control of all validation documentation,
Participation in internal and external audits (regulatory and client).
Engineering or Science degree
Deep Knowledge and expertise of core IT systems (MES, LIMS …)
Engineering or Science degree,
> 5 years validation experience in regulated environment,
Deep Knowledge and expertise of core IT systems (MES, LIMS …), computerized system validation, equipment qualification,
Ability to manage teams involving external resource ensuring delivery to schedule and budget,
Communicate effectively both verbally and written in English.
Our client is active in biotechnologies