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This is a temporary position supporting QA oversight of equipment, facilities, utilities qualification, and the associated systems lifecycle management activities for biologics with extensive focus on data integrity. This role offers a diverse breadth of accountability spanning all manufacturing equipment/processes, the embedded process automation systems, and analytical equipment. This individual will work closely with manufacturing, engineering and QC, guiding the plan and design phase of projects and continuous process improvements in the manufacturing plant and lab environments. Supporting partners in identifying and navigating risk-appropriate qualification strategies will be critical to success in this role.
