Senior Engineer, Automation

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).