Senior Process Engineer

Novartis • Durham, CA

3d • Onsite

About The Position

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.

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.

Nice To Haves

• Demonstrated experience delivering advanced capital projects, including large-scale equipment implementation from design through operational handover.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level