Sr. Automation Engineer - Downstream/Buffer
PharmaQuality Assurancegmpfdacroinform
Job description
Job Description Summary Ready to make a direct impact on the delivery of life-changing medicines? As a Sr. Automation Engineer - Downstream/Buffer, you will serve as a key technical leader supporting the automation systems that enable reliable, compliant, and efficient manufacturing operations. Working across complex GMP production environments, you'll drive automation strategy, lead critical projects, troubleshoot advanced control systems, and partner with cross-functional teams to continuously improve performance, quality, and operational excellence. This is an opportunity to combine deep technical expertise with meaningful influence in a highly collaborative manufacturing environment. Job Description Location: This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: Lead automation system design, configuration, maintenance, and lifecycle support across manufacturing operations. Serve as the technical SME for DCS, BMS, MES, and associated control systems. Drive automation project execution from concept through implementation and operational handoff. Oversee integration of third-party equipment into site automation and manufacturing platforms. Develop URS, FS, and design specifications to support compliant system delivery. Collaborate with cross-functional teams to establish priorities, timelines, and project objectives. Support new product introductions and ensure successful transition into GMP manufacturing. Investigate automation-related non-conformances and implement effective corrective actions. Execute change controls, system upgrades, and continuous improvement initiatives. Provide technical support for manufacturing operations, including participation in on-call rotations. Essential Requirements: Bachelor's degree in Engineering, Computer Science, or a related technical discipline. 8+ years of automation experience within GMP pharmaceutical or biopharmaceutical manufacturing environments. Hands-on experience supporting DCS platforms, preferably Emerson DeltaV. Proven expertise with PLC, SCADA, HMI, and manufacturing automation systems. Strong knowledge of validation practices, GMP regulations, FDA requirements, and 21 CFR Part 11. Experience applying ISA-88 principles and developing automation standards within regulated environments. Demonstrated project leadership experience, including management of contractors and external partners. Strong troubleshooting, communication, and technical writing skills with the ability to solve complex challenges. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $201,500 annually The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired Business Continuity, Cost Management, Decision Making, Operational Excellence, Problem Solving, Project Management, Quality Compliance, Risk Management, Stakeholder Management, Vendor Management
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