Overview The Senior Automation Engineer reports to the AD Process Automation and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis Aseptic Drug Product facility.Location Durham, NC (On‑Site). Novartis does not offer relocation support.Key Responsibilities Ensure automation aspects of new equipment are designed, meet Novartis standards, and are appropriately commissioned and qualified.Provide oversight for automation aspects of projects, including integration of 3rd party equipment with standard plant systems such as DCS, BMS, Historian, and infrastructure.Design, configure, install, and maintain automation software and associated hardware for existing equipment and processes.Prepare scopes of work for large projects, lead small teams, and manage automation contractors to complete required work within project timelines.Lead discussions with internal business partners on priorities, timelines, and transparent sharing of information.Develop, review, and approve lifecycle documentation (User Requirements, Functional Specification, Detail Design Specifications, etc.).Develop and maintain procedures to meet GMP requirements, CFRs, and internal company policies.Participate and/or lead new product implementation processes to ensure smooth transition from development to GMP manufacturing.Drive operational excellence and continuous improvement.Partner with Quality to ensure a quality and compliant manufacturing environment, including participation in regulatory audits as an automation SME.Resolve technical issues impacting production.Support 24x7 site‑based operations, including rotating on‑call responsibilities.Investigate non‑conformances related to automation systems.Perform other related duties as assigned.Essential Requirements B.S. degree in Engineering, Computer Science, or a related technical field.8 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations (or 12 years of equivalent experience).Excellent oral and written communication skills with demonstrated technical writing ability.Experience programming, troubleshooting, and maintaining site automation systems such as DCS, BMS, PLC, SCADA, historian, and infrastructure, including industrial protocols.Experience in development and execution of system level qualification testing and guidance on qualification plans in conjunction with C&Q department.Proven experience applying S88 methodology in an automated environment and developing control system standards aligning with S88.Experience in field wiring practices, panel design, troubleshooting and start‑up of control systems, and instrumentation.Experience writing and executing complex change controls.In‑depth knowledge of FDA regulations, particularly 21 CFR Part 11 and GMP systems.Strong project management skills with extensive experience in strategic/tactical planning and long‑term project planning.Ability to prepare contingency plans and logically work through complex issues under pressure.Provide technical support on all manufacturing issues toward resolution.Up to 10% travel may be required.Compensation and Benefits The salary range is $108,500 to $201,500 annually, based on qualifications and experience. The final salary will be reviewed periodically. Compensation includes a performance‑based cash incentive and eligibility for annual equity awards. US‑based eligible employees receive a comprehensive benefits package (health, life, and disability benefits, 401(k) with company contribution and match) and a generous time‑off package (vacation, personal days, holidays, and other leaves).#J-18808-Ljbffr