Novartis · 3 weeks ago
Senior Engineer, Automation
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
$108K/yr - $202K/yr
8+ years expNovartis is a leading pharmaceutical company, and they are seeking a Senior Automation Engineer to provide design team leadership and serve as a technical subject matter expert for their Aseptic Drug Product facility. The role involves overseeing automation aspects of projects, ensuring compliance with GMP requirements, and supporting site-based operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards and are appropriately commissioned and qualified
Provide oversight for automation aspects of projects including integration of 3rd party equipment to other standard plant systems, e.g., DCS, BMS, Historian, Infrastructure
Provide 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 as required to complete required work within project timelines
Lead discussions with internal business partners on priorities, timelines and transparent sharing of information
Develop, review and approve lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS)
Develop and maintain procedures to meet GMP requirements, CFR’s and internal company policies
Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing
Drive operational excellence and continuous improvement
Partner with Quality to ensure a quality and compliant manufacturing environment including participation in regulatory audits as an automation SME
Solve technical related issues impacting production
Support 24x7 site-based operations including rotating on-call responsibilities
Support investigations of non-conformances related to automation systems
Other related duties as assigned
Qualification
Required
B.S. degree in Engineering, Computer Science, or related technical field
8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations
Excellent oral and written communication skills, including demonstrated technical writing skills
Experience programming, troubleshooting, and maintaining various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols
Experience in development and execution of system level qualification testing including providing guidance on qualification plans in conjunction with C&Q department
Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology
Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation
Experience writing and executing complex change controls
In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems
Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning
Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere
Provide technical support on all manufacturing issues when driving towards issue resolution
Up to 10% travel may be required
Benefits
Performance-based cash incentive
Eligibility to be considered for annual equity awards
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
Pharmaceutical Technology
2026-01-19
Pharma Letter
2026-01-18
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