Process Engineer III

Healthcare Businesswomen’s Association; United States; On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC seeks a Process Engineer III to provide engineering support for GMP manufacturing equipment, utilities, facilities, and QC laboratory systems. You will lead lifecycle activities, drive continuous improvement, and collaborate across cross-functional teams to solve complex technical challenges.

The role requires a 5+ year background in pharmaceutical GMP manufacturing, strong knowledge of FDA regulations, and excellent problem-solving, writing, and stakeholder management

Qualifications

• Bachelor's degree in a related technical field with 5+ years of pharmaceutical or biopharmaceutical GMP manufacturing experience.
• Experience supporting GMP equipment and instrumentation in manufacturing, laboratory, facility, or utility environments across 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.
• Broad technical knowledge of equipment, instrumentation, installation, maintenance, and C&Q activities.

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 GMP laboratory equipment and systems across QC operations.
• 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, FS, and DDS.
• Partner with Manufacturing, Quality, Validation, and Technical Operations teams to evaluate new technologies and support future site needs.

Skills

Business Continuity

Cost Management

Operational Excellence

Quality Compliance

Education

Bachelor's degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or related technical field

Job description

Job Description Summary

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.

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

Key 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.

Essential 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.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $98,700 and $183,300 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$98,700.00 - $183,300.00

Skills Desired

Business Continuity, Cost Management, Operational Excellence, Quality Compliance