The Process Validation & Technical Standards Individual Contributor will be responsible for developing Validation and Technical Standards and Guidelines for Process Validation and Technical Transfer programs across the Company’s internal and external manufacturing network. This individual will be a part of the Global Technical Operations team and will report to the Director of Validation and Technical Standards.
Primary responsibilities include developing and maintaining Process Validation, continued process verification and other technical standards. This will ensure that technical guidelines are fit for purpose across multiple modalities and are updated as new modalities are introduced to the Company pipeline. The role will also support the development of a Knowledge Management framework for the Global Technical Operations department
The role will also support internal and external sites as they build and execute Process validation and tech transfer strategy to support the Company product pipeline The role will work across multiple functions and collaborate closely with Global Product Development, Site Technical Services, Site Validation teams, Quality, and Regulatory functions to shape standards and guidelines that are compliant with current regulatory requirements and Alexion standards
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