Senior DeltaV Engineer, Drug Product
Novartis
September 03, 2026
On-site
Durham, NC
Operations
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.
Essential Requirements:
- 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.
Compensation/Benefits (as stated):
- 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).
- 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.
Essential Requirements:
- 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.
Compensation/Benefits (as stated):
- 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).