Sr. Principal Engineer, Aseptic DP Compounding Owner – Aseptic DP Compounding

Role: Senior Principal Engineer, Process Engineering System Owner for Aseptic Drug Product (DP) Compounding within biotherapeutics at Johnson & Johnson. Primary objectives include leading end-to-end process engineering for aseptic, biotherapeutic drug manufacturing, focusing on equipment design, system development, and regulatory compliance. Responsibilities encompass developing specifications for single-use and stainless steel equipment, vendor assessment, leading detailed design and validation (FAT, SAT, C&Q), and coordinating cross-functional activities for facility commissioning and start-up. Qualifications: Bachelor's in engineering (Chemical preferred), 10+ years in aseptic biotherapeutic drug compounding within cGMP environments, with proven expertise in single-use technology, stainless steel tank design, and process optimization. Preferred: experience managing large capital projects ($30-50M), green/brownfield GMP start-ups, and extensive stakeholder collaboration. High-Value: expertise in aseptic process design, equipment qualification, regulatory standards, and process automation. Location: Wilson, North Carolina, requiring full-time onsite presence with frequent travel (>75%) during project phases.