Senior Engineer, Automation
Novartis
3 months ago
On-site
Durham, NC
$108,500 - $201,500 USD yearly
Operations
Key Responsibilities:
- Ensure automation aspects of new equipment are designed per Novartis standards and are appropriately commissioned and qualified.
- Provide oversight for automation projects, including integration of 3rd-party equipment with plant systems (e.g., DCS, BMS, Historian, infrastructure).
- Perform design, configuration, installation, and maintenance of 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 meet timelines.
- Lead discussions with internal business partners on priorities, timelines, and transparent information sharing.
- Develop, review, and approve lifecycle documentation (URS, Functional Specifications, Detail Design Specifications).
- Develop and maintain procedures to meet GMP requirements, CFRs, and internal policies.
- Participate and/or lead new product implementation to ensure smooth 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 non-conformances related to automation systems.
Essential Requirements:
- B.S. in Engineering, Computer Science, or related field.
- 8+ years GMP pharma/biopharma manufacturing operations experience (or 12 years equivalent).
- Excellent oral/written communication; strong technical writing.
- Experience programming, troubleshooting, and maintaining automation systems (DCS, BMS, PLC, SCADA, historian, infrastructure) and industrial protocols.
- Experience with system-level qualification testing and guiding qualification plans with C&Q.
- Proven S88 experience and development of control system standards aligned with S88.
- Field wiring practices, panel design, control system troubleshooting/start-up, instrumentation.
- 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; contingency planning under pressure.
- Provide technical support to resolve manufacturing issues.
- Up to 10% travel.
Compensation/Benefits (as stated):
- Salary expected range: $108,500–$201,500 annually.
- Performance-based cash incentive; eligibility for annual equity awards depending on level.
- Comprehensive benefits package (health, life, disability, 401(k) with company contribution/match) and time off (vacation, personal days, holidays, other leaves).
Application/location notes (as stated):
- On-site role in Durham, NC. No relocation support.
- Ensure automation aspects of new equipment are designed per Novartis standards and are appropriately commissioned and qualified.
- Provide oversight for automation projects, including integration of 3rd-party equipment with plant systems (e.g., DCS, BMS, Historian, infrastructure).
- Perform design, configuration, installation, and maintenance of 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 meet timelines.
- Lead discussions with internal business partners on priorities, timelines, and transparent information sharing.
- Develop, review, and approve lifecycle documentation (URS, Functional Specifications, Detail Design Specifications).
- Develop and maintain procedures to meet GMP requirements, CFRs, and internal policies.
- Participate and/or lead new product implementation to ensure smooth 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 non-conformances related to automation systems.
Essential Requirements:
- B.S. in Engineering, Computer Science, or related field.
- 8+ years GMP pharma/biopharma manufacturing operations experience (or 12 years equivalent).
- Excellent oral/written communication; strong technical writing.
- Experience programming, troubleshooting, and maintaining automation systems (DCS, BMS, PLC, SCADA, historian, infrastructure) and industrial protocols.
- Experience with system-level qualification testing and guiding qualification plans with C&Q.
- Proven S88 experience and development of control system standards aligned with S88.
- Field wiring practices, panel design, control system troubleshooting/start-up, instrumentation.
- 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; contingency planning under pressure.
- Provide technical support to resolve manufacturing issues.
- Up to 10% travel.
Compensation/Benefits (as stated):
- Salary expected range: $108,500–$201,500 annually.
- Performance-based cash incentive; eligibility for annual equity awards depending on level.
- Comprehensive benefits package (health, life, disability, 401(k) with company contribution/match) and time off (vacation, personal days, holidays, other leaves).
Application/location notes (as stated):
- On-site role in Durham, NC. No relocation support.