Novartis

Pharmaceutical

ProcessEngineerIII

$99–99k Durham, North Carolina, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Process Engineer III at Novartis. Skills: Process Engineering, Manufacturing Equipment, GMP Compliance. Provide engineering support. Provide validation support”

Industry & Context.

Pharmaceutical
Problems you'll solve

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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