Novartis
Pharmaceutical
ProcessEngineerIII
Neural analysis suggests this role is
optimal for Senior candidates.
“Process Engineer III at Novartis. Skills: Process Engineering, Manufacturing Equipment, GMP Compliance. Provide engineering support. Provide validation support”
Industry & Context.
Analyze complex issues; Implement effective solutions
What They're Looking For.
Must Have
Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related technical field, Minimum 5 years pharmaceutical or biopharmaceutical GMP manufacturing experience, 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, Project management skills, Excellent written and verbal communication skills, Technical writing capabilities, Ability to analyze complex issues, Implement effective, compliant engineering solutions
Nice to Have
Relocation support not offered
What You'll Do.
Provide engineering support
Provide validation support
Provide maintenance support
Ensure systems operate compliant
Ensure systems operate reliable
Ensure systems operate efficient
Ensure new equipment is designed
Ensure new equipment is qualified
Ensure new equipment is maintained
Own equipment changes
Manage equipment changes
Investigate equipment issues
Investigate process issues
Implement corrective actions
Prevent recurrence of issues
Serve as subject matter expert
Respond to regulatory observations
Develop maintenance strategies
Implement maintenance strategies
Lead capital projects
Support capital projects
Provide technical guidance
Collaborate with operations
Support new product introductions
Evaluate facility fit
Establish equipment specifications
Evaluate new technologies
Implement new technologies
Mentor process engineers
Optimize engineering systems
Optimize engineering processes
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Technical writing
Process & Methodology
Strategic planning, Long-term planning
Full Job Description
**Job Description Summary** 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. **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:** * 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 **Essential 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 re
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