Senior Process Engineer

Job Description Summary #LI-Onsite #EngineeringJobs #ProcessEngineering #AsepticManufacturing #FillFinish #Automation #CapitalProjects #NovartisCareers Location: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. If you thrive where precision meets purpose, this is your chance to shape how aseptic drug product is packaged, inspected, and delivered—by bringing new automated fill/finish and packaging equipment online for the aseptic drug product expansion in Durham. You will lead engineering and validation activities for a major capital project, owning the strategy that ensures equipment and processes remain compliant throughout their lifecycle. From automated inspection performance and packaging line capability to robust deviation investigations and corrective actions, your work will directly strengthen reliability, inspection readiness, and day-to-day operational excellence.   Job Description Key Responsibilities Lead design, installation, qualification, and lifecycle support of aseptic fill and finish, packaging, and automated inspection equipment. Serve as subject matter expert for new automated equipment supporting the aseptic drug product expansion capital project. Own equipment change management to maintain validated state and Good Manufacturing Practice compliance. Investigate equipment and process deviations, performing root cause analysis and implementing corrective and preventive actions. Support regulatory inspections and internal audits as engineering subject matter expert. Develop compliant and cost-effective equipment reliability and maintenance strategies. Define equipment requirements and specifications, including User Requirements and functional design documentation. Partner with operations and manufacturing sciences on new product introductions and facility fit assessments. Evaluate new technologies and equipment platforms supporting long-term automation and capacity strategy. Mentor engineers and lead cross-functional teams to improve engineering systems and processes. Essential Requirements Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering with 8 years of experience with the pharmaceutical industry, or 12 years relevant experience within the pharmaceutical industry in lieu of a degree. Extensive experience supporting aseptic fill and finish drug product manufacturing. Strong expertise with packaging lines and automated inspection systems. In-depth knowledge of Food and Drug Administration (FDA) regulations and Good Manufacturing Practice (GMP) requirements. Experience leading equipment qualification, validation strategies, and change management. Strong technical writing skills for regulated engineering documentation. Ability to lead cross-functional teams and manage complex capital initiatives. Excellent communication, organizational, and problem-solving skills. Desirable Requirements Demonstrated experience delivering advanced capital projects, including large-scale equipment implementation from design through operational handover. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 to $201,500 per year. 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. To learn more about the culture, rewards and benefits we offer our people click here. Company will not sponsor visas for this position.    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, Data Analytics and Digital, Decision Making, Engineering Operations Management, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process (Production), Operational Excellence, Problem Solving, Project Management, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Risk Management, Stakeholder Management, Vendor Management