Pharma Packaging Process Engineer: Automation & Scale-Up

Katalyst CRO; Durham (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Packaging Process Engineer to support a major pharmaceutical manufacturing expansion in Durham, NC. The role encompasses technical leadership for packaging operations, equipment implementation, commissioning, qualification, process optimization, and readiness for commercial manufacture.

The ideal candidate will collaborate across Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering, ensuring equipment reliability and regulatory

Qualifications

• Bachelor-level engineering degree required in a related discipline.
• 5+ years of pharmaceutical manufacturing experience with direct packaging operations involvement.
• Experience with automated packaging equipment in GMP-regulated environments.
• Strong understanding of packaging equipment validation, startup, and qualification.
• Knowledge of FDA cGMP, EU GMP, and pharma packaging best practices.
• Experience leading process improvements and equipment reliability initiatives.
• Excellent troubleshooting, technical writing, communication, and cross-functional collaboration skills.

Responsibilities

• Provide technical leadership for pharmaceutical packaging operations during expansion.
• Support equipment implementation, commissioning, qualification, and process optimization.
• Collaborate with Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering to ensure reliability and regulatory compliance.

Skills

Packaging engineering

Process optimization

GMP compliance

Troubleshooting

Cross-functional collaboration

Technical writing

Documentation

Project coordination

Education

Bachelor's degree in Engineering (Mechanical/Manufacturing/Packaging)

Tools

MES

SAP

TrackWise

Job description

Katalyst CRO is seeking an experienced Packaging Process Engineer to support a major pharmaceutical manufacturing expansion in Durham, NC. The role encompasses technical leadership for packaging operations, equipment implementation, commissioning, qualification, process optimization, and readiness for commercial manufacture.

The ideal candidate will collaborate across Manufacturing, QA, Validation, Automation, Maintenance, and Project Engineering, ensuring equipment reliability and regulatory