Process Engineer III

Novartis • Durham, CA

13d • $98,700 - $183,300 • Onsite

About The Position

Join a team committed to delivering life-changing therapies to patients worldwide. As a Process Engineer III, you will provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement across operations. This role offers the opportunity to lead strategic engineering initiatives, solve complex technical challenges, and apply experience with fill finish/drug product equipment and Clean-in-Place (CIP)/Steam-in-Place (SIP) systems in a dynamic pharmaceutical manufacturing environment.

Requirements

• Bachelor’s degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field.
• Minimum five years of experience in pharmaceutical or biopharmaceutical Good Manufacturing Practice manufacturing operations.
• Strong knowledge of United States Food and Drug Administration regulations and Good Manufacturing Practice systems in regulated environments.
• Excellent written and verbal communication skills, including technical documentation and report writing.
• Experience supporting manufacturing equipment, facilities, and utility systems within pharmaceutical or biotechnology operations.
• Demonstrated project management experience with the ability to lead complex initiatives and long-term planning activities.
• Proven ability to investigate technical issues, analyze data, and implement effective solutions in fast-paced environments.
• Experience leading cross-functional teams and collaborating across multiple functions to achieve business objectives.

Nice To Haves

• Experience supporting fill finish or drug product manufacturing equipment.
• Experience with Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.

Responsibilities

• Lead equipment lifecycle activities to ensure compliant, reliable, and validated manufacturing operations.
• Define and optimize equipment qualification and validation strategies for new and existing systems.
• Own process equipment changes to maintain validated state and drive operational improvements.
• Investigate equipment and process deviations, implementing effective corrective and preventive actions.
• Serve as a subject matter expert during regulatory inspections and internal audits.
• Develop and implement equipment reliability and maintenance strategies that support business objectives.
• Lead capital projects and provide engineering expertise for facility and equipment enhancements.
• Create and maintain technical documentation, including User Requirements, Functional Specifications, and Design Specifications.
• Partner with Operations and Manufacturing Sciences to support new product introductions and facility fit assessments.
• Evaluate and implement innovative manufacturing technologies to support long-term site strategy.

Benefits

• Performance-based cash incentive
• Eligibility for annual equity awards
• Health benefits
• Life benefits
• Disability benefits
• 401(k) with company contribution and match
• Generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

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