Lead - Biomanufacturing Compliance - Investigator, Deviations

About Site Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem. Position Summary We have an opportunity for a Lead - Biomanufacturing Compliance - Investigator, Deviations to join our team. In this role, you will be responsible for authoring and revising deviation records and related cGMP documents while ensuring timely and accurate completion. You will collaborate with manufacturing and quality systems, support audits, and contribute to a strong compliance culture. This position offers the chance to actively participate in inspection readiness and continuous improvement initiatives. Shift: Mon-Friday, core hours 9am-4pm Location: Madison, WI 100% Onsite The Role Author and revise complex deviation records, preventative actions, and other related cGMP documents in a timely manner. Apply working knowledge of upstream, downstream, materials management, production facility, systems, and technologies to ensure accurate completion of responsibilities. Track, monitor, and provide timely, accurate information regarding the status of open investigations. Lead initiatives to improve process compliance culture, including ongoing cGMP understanding and application. Lead Inspection Readiness activities and teams. Write and revise Standard Operating Procedures, proactively identifying gaps. Provide support to internal and client audits regarding the status of deviations and Corrective and Preventive Actions. Exhibit professional behavior with internal and external associates consistent with company policies and practices. Participate regularly in team meetings for biomanufacturing compliance support. Perform other duties as assigned. The Candidate Minimum Requirements High School Diploma or GED with at least 7+ years of related experience, or an Associate’s degree in a STEM field with 6+ years of related experience. 3+ years of experience required with a Bachelor’s degree in a STEM-related field, or an MS/PhD in a technical discipline without formal experience. Experience in deviation writing and with Root Cause Analysis and Corrective and Preventive Action implementation. Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®. Ability to apply cGMP principles and best practices to ensure compliant, high-quality execution of procedures. Foundational knowledge of manufacturing and laboratory operations, with the ability to learn new processes and techniques. Experience with deviation investigations, including corrective and preventive actions. Experience authoring and editing Standard Operating Procedures and related documentation. Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, …

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