Senior Automation Engineer
Novartis
August 24, 2026
On-site
Durham, NC
IT
Key Responsibilities:
- Provide design, configuration, installation, and maintenance of automation software and associated hardware; coordinate with other teams.
- Oversee/participate in automation for future projects, including integration of 3rd-party equipment to plant DCS/BMS; data concentration, batch reporting, and data retention.
- Prepare scopes of work and manage automation contractors to meet project timelines.
- Develop project objectives from user requirements and business plans.
- Define equipment/system specifications and select cost-effective technology.
- Lead discussions with business partners on priorities, timelines, and transparent information sharing.
- Establish specifications in URS/FS/DDS (HDS/SDS) documentation.
- Take programs from concept through execution; manage all project stages with project management tools.
- Maintain procedures to meet GMP, CFRs, and internal policies.
- Participate/lead new product implementation to transition from development to GMP manufacturing.
- Drive operational excellence/continuous improvement; partner with Quality for compliance.
- Troubleshoot technical issues impacting production; support 24x7 operations via rotating on-call.
- Create/update procedures and implement/revise SOPs; deploy/maintain/upgrade manufacturing applications.
- Investigate automation-related non-conformances; analyze data and recommend improvements/remediation.
- Execute change controls for automation systems and equipment.
Essential Requirements:
- B.S. in Engineering, Computer Science, or related field.
- 8 years GMP pharmaceutical/biopharmaceutical manufacturing experience (or 12 years equivalent).
- Excellent oral/written communication and technical writing.
- Experience programming/troubleshooting/maintaining DCS (DeltaV); SCADA/HMI (Rockwell FactoryTalk View SE); PLC/BMS (Allen Bradley CompacLogix/ControlLogix); data historian (OSI PI).
- Experience with statistical analysis (Statistica) and MES (OpsTrakker).
- Experience with system-level validation testing and guidance with C&Q.
- Proven S88 application and development of control system standards.
- Field wiring/panel design; troubleshooting/start-up; instrumentation knowledge.
- Industrial protocols (MODBUS, Ethernet/IP, etc.).
- Write/execute complex change controls.
- Develop MS SQL queries.
- In-depth knowledge of 21 CFR Part 11 and GMP.
- Knowledge of Quality by Design, six-sigma, operational excellence.
- Manage 3rd parties (in- and outsourcing).
- Strong project management and contingency planning; technical support to resolve manufacturing issues.
- Up to 10% travel.
Benefits:
- Salary expected: $108,500–$201,500 annually; performance-based cash incentive; potential annual equity awards depending on level; US benefits include health, life/disability, 401(k) with match, and time off.
Location: Durham, NC (onsite); no relocation support.
- Provide design, configuration, installation, and maintenance of automation software and associated hardware; coordinate with other teams.
- Oversee/participate in automation for future projects, including integration of 3rd-party equipment to plant DCS/BMS; data concentration, batch reporting, and data retention.
- Prepare scopes of work and manage automation contractors to meet project timelines.
- Develop project objectives from user requirements and business plans.
- Define equipment/system specifications and select cost-effective technology.
- Lead discussions with business partners on priorities, timelines, and transparent information sharing.
- Establish specifications in URS/FS/DDS (HDS/SDS) documentation.
- Take programs from concept through execution; manage all project stages with project management tools.
- Maintain procedures to meet GMP, CFRs, and internal policies.
- Participate/lead new product implementation to transition from development to GMP manufacturing.
- Drive operational excellence/continuous improvement; partner with Quality for compliance.
- Troubleshoot technical issues impacting production; support 24x7 operations via rotating on-call.
- Create/update procedures and implement/revise SOPs; deploy/maintain/upgrade manufacturing applications.
- Investigate automation-related non-conformances; analyze data and recommend improvements/remediation.
- Execute change controls for automation systems and equipment.
Essential Requirements:
- B.S. in Engineering, Computer Science, or related field.
- 8 years GMP pharmaceutical/biopharmaceutical manufacturing experience (or 12 years equivalent).
- Excellent oral/written communication and technical writing.
- Experience programming/troubleshooting/maintaining DCS (DeltaV); SCADA/HMI (Rockwell FactoryTalk View SE); PLC/BMS (Allen Bradley CompacLogix/ControlLogix); data historian (OSI PI).
- Experience with statistical analysis (Statistica) and MES (OpsTrakker).
- Experience with system-level validation testing and guidance with C&Q.
- Proven S88 application and development of control system standards.
- Field wiring/panel design; troubleshooting/start-up; instrumentation knowledge.
- Industrial protocols (MODBUS, Ethernet/IP, etc.).
- Write/execute complex change controls.
- Develop MS SQL queries.
- In-depth knowledge of 21 CFR Part 11 and GMP.
- Knowledge of Quality by Design, six-sigma, operational excellence.
- Manage 3rd parties (in- and outsourcing).
- Strong project management and contingency planning; technical support to resolve manufacturing issues.
- Up to 10% travel.
Benefits:
- Salary expected: $108,500–$201,500 annually; performance-based cash incentive; potential annual equity awards depending on level; US benefits include health, life/disability, 401(k) with match, and time off.
Location: Durham, NC (onsite); no relocation support.