Equipment- Process Validation Manager

Key Responsibilities: Provide process validation troubleshooting support for all equipment/unit operations and processes on site related to Sanford's Vaccine or other products. Lead and/or participates in the planning, preparation and execution of process validations, including continued process verification, as well as supporting tech transfer activities and related projects. This includes generation of protocols and cleaning assessments, direct sampling of equipment, working with manufacturing to align sample schedules, understanding Delta V controls, and pulling data from LIMs. Lead or co-lead moderately complex projects, managing time and resources effectively while providing guidance. Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems. Operate independently in ambiguous situations, determining objectives of assignments and seeking directional review when necessary. Review your own work and potentially mentor others, exercising judgment and becoming a resource for colleagues. Guide operational teams in project management, resource forecasting, and identifying areas for improvement in products, processes, or services. Facilitate agreements between teams to achieve project goals and coordinate validation/qualification work, including plans, strategies, and risk assessments. Review and approve change controls, ensuring validation impact assessments and appropriate testing to maintain validated states. Collaborate with Operations, Quality, Technical groups, and other site/network groups to meet business and compliance requirements. Think through issues and troubleshoot problems related to cleaning and processing, work with the investigations group to provide technical justifications, understanding changes to cleaning and process systems, and interact with regulatory authorities during audits. Provide technical support, participate in change control implementations, deliver validation training, and ensure compliance with company policies and government regulations. Non-Standard Work Schedule, Travel or Environment RequirementsSchedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.