Senior Engineer, Automation - Packaging/Serialization

Novartis; North Carolina; On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis in Durham, NC seeks a Senior Engineer, Automation - Packaging/Serialization to lead automation for packaging and serialization across manufacturing operations. You will act as the SME for DCS, BMS, MES, and related control systems, guiding projects from concept to handoff.

You will drive standardization, validation, and equipment integration within GMP manufacturing, collaborating with cross-functional teams, and supporting on-call operations.

Qualifications

• 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.

Responsibilities

• Lead automation support for packaging and serialization systems 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 packaging equipment and serialization technologies into site automation 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 launches and packaging implementation activities within 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.

Skills

Automation systems

GMP manufacturing

ISA-88

Project leadership

Validation practices

FDA requirements

21 CFR Part 11

Troubleshooting

Technical writing

Communication

Education

Bachelor's degree in Engineering, Computer Science, or related technical discipline

Tools

Emerson DeltaV

Job description

Job Description Summary

Ready to help ensure life-changing medicines reach patients safely and reliably? As a Senior Engineer, Automation - Packaging/Serialization, you will provide technical leadership for the automation systems that support packaging operations, serialization processes, and product traceability across the manufacturing environment. Working within a GMP-regulated facility, you'll drive automation innovation, enhance system performance, and lead critical projects that strengthen compliance, operational efficiency, and supply chain integrity. This role offers the opportunity to make a visible impact on how products are packaged, tracked, and delivered to patients worldwide.

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 support for packaging and serialization systems 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 packaging equipment and serialization technologies into site automation 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 launches and packaging implementation activities within 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.

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

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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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.