Position Summary:
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety. Role Requirements/ Qualifications Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience. Strong understanding of validation principles and practices Experience with FDA and EU regulatory requirements and guidelines for validation Experience with technical transfers Proficiency in project management and resource planning Ability to work independently and make decisions in ambiguous situations Excellent communication and interpersonal skills Proficiency in computerized systems and software applications Nice-to-have/ Preferred Demonstrated process and/or cleaning validation experience in a biopharmaceutical/pharmaceutical GMP environment Additional experience in other areas of validation
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 Requirements Schedule 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.
