Process Engineer III

Novartis • Durham, NC

10d • Onsite

About The Position

Step into a pivotal engineering role where your expertise directly shapes the future of advanced manufacturing. As a Process Engineer III, you will provide engineering, validation, and maintenance support for process manufacturing equipment, facilities, and utilities at the site. In this hands-on position, you will ensure systems operate in a compliant, reliable, and efficient manner throughout their lifecycle—helping to drive operational excellence and deliver high-quality therapies to patients.

Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related technical field
• Minimum 5 years pharmaceutical or biopharmaceutical GMP manufacturing experience, or equivalent experience
• Strong knowledge of FDA regulations and GMP systems
• Demonstrated experience supporting engineering activities in a regulated pharmaceutical or biotechnology environment
• Proven ability to lead cross-functional teams in a fast-paced and dynamic setting
• Strong project management skills with experience in both strategic and long-term planning
• Excellent written and verbal communication skills with strong technical writing capabilities
• Ability to analyze complex issues and implement effective, compliant engineering solutions

Nice To Haves

• Business Continuity
• Change Control
• Cost Management
• Data Analytics and Digital
• Engineering Technical Expertise
• GDP Knowledge
• gmp knowledge
• HSE Knowledge
• Knowledge Of Relevant Tools And Systems
• Manufacturing Process (Production)
• Operational Excellence
• Quality Compliance
• Resilience and Risk Management
• Total Productive Maintenance

Responsibilities

• Ensure new equipment is appropriately designed, qualified, and maintained across the equipment lifecycle
• Own and manage equipment changes to maintain a validated and compliant state
• Investigate equipment and process deviations; implement corrective actions to prevent recurrence
• Serve as subject matter expert during audits and respond to regulatory observations
• Develop and implement compliant and effective equipment reliability and maintenance strategies
• Lead or support capital projects, providing subject matter expertise and technical guidance
• Collaborate with operations to support new product introductions and facility fit evaluations
• Establish equipment specifications including user requirements, functional, and design specifications
• Evaluate and implement new technologies and equipment platforms for manufacturing operations
• Mentor process engineers and lead small teams to optimize engineering systems and processes

Benefits

• Health insurance
• Life insurance
• Disability insurance
• 401(k) with company contribution and match
• Performance-based cash incentive
• Eligibility for annual equity awards
• Vacation
• Personal days
• Holidays
• Other leaves

What This Job Offers

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