Pharma Process Engineer III: Equipment & CIP/SIP (Onsite)

Novartis; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC is seeking a Process Engineer III to provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement in a GMP pharmaceutical setting.

The role offers opportunities to lead strategic engineering initiatives, handle CIP/SIP systems, and support new product introductions while ensuring validated state and regulatory readiness.

Qualifications

• Bachelor’s degree in a related engineering field.
• 5+ years experience in pharmaceutical or biopharmaceutical GMP manufacturing.
• Strong knowledge of FDA regulations and GMP systems.
• Excellent written and verbal communication skills for technical documentation.
• Experience supporting manufacturing equipment, facilities, and utilities in pharma/biotech.
• Demonstrated project management experience leading complex initiatives.

Responsibilities

• Lead equipment lifecycle activities to ensure compliant, reliable, and validated manufacturing operations.
• Define and optimize equipment qualification and validation strategies for new and existing systems.
• Own process equipment changes to maintain validated state and drive operational improvements.
• Investigate equipment and process deviations, implementing corrective and preventive actions.
• Serve as a subject matter expert during regulatory inspections and internal audits.
• Develop and implement equipment reliability and maintenance strategies.
• Lead capital projects and provide engineering expertise for facility and equipment enhancements.
• Create and maintain technical documentation (URs, FSs, DSs).
• Partner with Operations and Manufacturing Sciences for new product introductions and facility fit assessments.

Skills

Technical communication

Project management

Regulatory compliance

Cross-functional teamwork

Data analysis

Technical writing

Education

Bachelor's degree in Chemical/Electrical/Mechanical Engineering

Tools

CIP/SIP systems

Qualification/Validation

Job description

Novartis in Durham, NC is seeking a Process Engineer III to provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement in a GMP pharmaceutical setting.

The role offers opportunities to lead strategic engineering initiatives, handle CIP/SIP systems, and support new product introductions while ensuring validated state and regulatory readiness.