Senior DeltaV Engineer, Drug Prodcut
Novartis
August 13, 2026
On-site
Durham, NC
Operations
Key Responsibilities
- Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards, and are commissioned and qualified.
- Oversee automation for projects, 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; manage automation contractors to meet timelines.
- Lead discussions with business partners on priorities, timelines, and transparent information sharing.
- Develop/review/approve lifecycle documentation (URS, FS, DDS/HDS/SDS).
- Develop/maintain GMP-compliant procedures aligned with CFRs and internal policies.
- Participate in and/or lead new product implementation for transition to 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-related non-conformances; other duties as assigned.
Essential Requirements & Qualifications
- B.S. in Engineering, Computer Science, or related technical field.
- 8+ years pharmaceutical/biopharmaceutical GMP manufacturing experience (or 12+ years equivalent).
- Excellent oral/written communication, including technical writing.
- Experience programming/troubleshooting/maintaining automation systems (DCS, BMS, PLC, SCADA, historian, infrastructure) and industrial protocols.
- Qualification testing experience, including guidance on qualification plans with C&Q.
- Proven S88 experience and development of control system standards aligned with S88.
- Field wiring, panel design, control system troubleshooting/start-up, and instrumentation experience.
- Experience writing/executing complex change controls.
- In-depth knowledge of FDA regulations, especially 21 CFR Part 11 and GMP systems.
- Strong project management and long-term planning; ability to develop contingency plans.
- Up to 10% travel.
Location/Application
- On-site role in Durham, NC. No relocation support; apply only if accessible to you.
- Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards, and are commissioned and qualified.
- Oversee automation for projects, 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; manage automation contractors to meet timelines.
- Lead discussions with business partners on priorities, timelines, and transparent information sharing.
- Develop/review/approve lifecycle documentation (URS, FS, DDS/HDS/SDS).
- Develop/maintain GMP-compliant procedures aligned with CFRs and internal policies.
- Participate in and/or lead new product implementation for transition to 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-related non-conformances; other duties as assigned.
Essential Requirements & Qualifications
- B.S. in Engineering, Computer Science, or related technical field.
- 8+ years pharmaceutical/biopharmaceutical GMP manufacturing experience (or 12+ years equivalent).
- Excellent oral/written communication, including technical writing.
- Experience programming/troubleshooting/maintaining automation systems (DCS, BMS, PLC, SCADA, historian, infrastructure) and industrial protocols.
- Qualification testing experience, including guidance on qualification plans with C&Q.
- Proven S88 experience and development of control system standards aligned with S88.
- Field wiring, panel design, control system troubleshooting/start-up, and instrumentation experience.
- Experience writing/executing complex change controls.
- In-depth knowledge of FDA regulations, especially 21 CFR Part 11 and GMP systems.
- Strong project management and long-term planning; ability to develop contingency plans.
- Up to 10% travel.
Location/Application
- On-site role in Durham, NC. No relocation support; apply only if accessible to you.