Process Engineer III

Novartis•Durham, NC

2d•Onsite

About The Position

Make a meaningful impact by ensuring the reliability and compliance of the equipment and systems that support the development and manufacture of innovative therapies. As a Process Engineer III, you will provide engineering support for GMP manufacturing equipment, utilities, facilities, and a broad range of QC laboratory systems. You'll lead equipment lifecycle activities including installation, commissioning and qualification (C&Q), validation, maintenance, and continuous improvement while partnering with cross-functional teams to solve complex technical challenges and support operational excellence.

Requirements

Bachelor's degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field with 5+ years of pharmaceutical or biopharmaceutical GMP manufacturing experience, or equivalent industry experience.
Demonstrated experience supporting GMP equipment and instrumentation in manufacturing, laboratory, facility, or utility environments throughout the equipment lifecycle.
Strong knowledge of FDA regulations, GMP requirements, validation principles, and regulated manufacturing environments.
Proven ability to investigate deviations, perform root cause analysis, and implement effective CAPAs.
Experience leading cross-functional projects and managing multiple priorities in a fast-paced environment.
Excellent technical writing, communication, organizational, and stakeholder management skills.
Ability to solve complex technical challenges, exercise sound judgment, and drive effective engineering solutions.
Broad technical knowledge of equipment, instrumentation, installation, maintenance, and C&Q activities; experience in a specific QC laboratory discipline is not required.

Nice To Haves

Business Continuity
Cost Management
Operational Excellence
Quality Compliance

Responsibilities

Lead GMP equipment lifecycle activities, including installation, commissioning, qualification (C&Q), validation, and ongoing maintenance.
Ensure new equipment is appropriately designed, qualified, and maintained in a compliant and validated state.
Manage process equipment changes and support continuous improvement initiatives across site operations.
Investigate equipment and process deviations, perform root cause analysis, and implement effective CAPAs.
Provide engineering and instrumentation support for a broad range of GMP laboratory equipment and systems across QC operations, including PCR, Biochemistry, Microbiology, and Bioassay laboratories.
Serve as a subject matter expert during FDA inspections and internal audits, addressing observations and supporting compliance activities.
Develop and implement equipment reliability and maintenance strategies that improve performance and reduce operational risk.
Lead or provide SME support for capital projects, technology upgrades, and facility improvement initiatives.
Create and maintain engineering documentation, including URS, Functional Specifications (FS), and Detailed Design Specifications (DDS).
Partner with Manufacturing, Quality, Validation, and Technical Operations teams to evaluate new technologies and support future site needs.