Engineer

Key Responsibilities: Monitor and analyze process performance data to support continued process verification and product quality. Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges. Trend critical quality attributes and process parameters to identify risks and drive improvements. Support technology transfer activities for new products and processes into commercial manufacturing. Identify and implement continuous improvement opportunities that enhance operational performance. Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment. Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply. Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams. Contribute to the startup and implementation of new equipment, software, and manufacturing processes. Provide technical support for strategic projects, remediation initiatives, and process optimization efforts. Essential Requirements: Bachelor’s in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish); or 3+ years direct Novartis Gene Therapies experience with aseptic fill-finish; or Master’s with 2+ years relevant aseptic fill-finish or engineering experience. Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles. Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations. Strong technical writing skills for accurate, compliant documentation. Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders. Ability to travel up to 10%. Benefits (explicitly stated): Salary expected range: $89,600–$166,400 annually; performance-based cash incentive; eligibility for annual equity awards (depending on level). US-based comprehensive benefits (health, life/disability), 401(k) match, time off (vacation, personal days, holidays, other leaves). Onsite in Durham, NC; no relocation support—apply only if location is accessible. #J-18808-Ljbffr