Senior DeltaV Engineer, Drug Product

Key Responsibilities:

• Ensure automation aspects of new equipment are designed to Novartis standards and are commissioned and qualified.
• Provide oversight for automation project work, including integration of 3rd-party equipment with standard plant systems (e.g., DCS, BMS, Historian, infrastructure).
• Design, configure, install, and maintain automation software and associated hardware for existing equipment/processes.
• Prepare scopes of work, lead small teams, and manage automation contractors to meet project timelines.
• Lead discussions with internal partners on priorities, timelines, and information sharing.
• Develop, review, and approve lifecycle documentation (URS, FS, DDS/HDS/SDS).
• Develop/maintain procedures to meet GMP, CFRs, and internal policies.
• Participate/lead new product implementation to transition into GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Partner with Quality; participate in regulatory audits as an automation SME.
• Solve technical issues impacting production.
• Support 24x7 operations with rotating on-call.
• Support investigations of automation non-conformances.

• B.S. in Engineering/Computer Science/related field.
• 8 years GMP pharmaceutical/biopharma manufacturing experience (or 12 years equivalent).
• Excellent oral/written communication and technical writing.
• Programming, troubleshooting, and maintenance experience with DCS, BMS, PLC, SCADA, historians, infrastructure, and industrial protocols.
• Qualification testing experience; guidance on qualification plans with C&Q.
• Proven S88 experience and control system standards aligned to S88.
• Field wiring practices/panel design; troubleshooting/start-up; instrumentation experience.
• Experience with complex change controls.
• In-depth FDA/21 CFR Part 11 and GMP knowledge.
• Strong project management and long-term planning skills.
• Ability to prepare contingency plans and work through complex issues under pressure.
• Up to 10% travel may be required.

• Salary expected: $108,500-$201,500 annually; performance-based cash incentive; potential annual equity awards (depending on level).
• US-based eligible employees: health/life/disability, 401(k) with match, and time off (vacation/personal days/holidays/leaves).