Senior Packaging Equipment Engineer - GMP & CQV Lead

3key Consulting, Inc.; New Albany (OH); On-site; USD 87,000 - 96,000; Part time

Job summary

3 Key Consulting is seeking a Senior Process Development Engineer for a GMP packaging equipment program in New Albany, Ohio. This contract role requires hands-on support of highly automated packaging systems, CQV leadership, and cross-functional collaboration to drive process improvements.

Ideal candidates hold a B.S. in Engineering with 4+ years of GMP experience and are comfortable with 12-hour rotating shifts and up to 10% travel.

Qualifications

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Responsibilities

• Manufacturing Support: Partner with Manufacturing, Quality, Engineering, Validation, Automation, and Packaging Engineering to support operations and equipment windows.
• Packaging Equipment Support: Provide hands-on technical support for automated packaging and device assembly equipment, troubleshooting issues.
• Equipment Characterization & CQV: Lead characterization, commissioning, qualification, and validation activities to establish parameters and controls.
• GMP Documentation: Author and manage protocols, reports, risk assessments, deviations, CAPAs, and change controls in KNEAT/Veeva.
• Troubleshooting & Continuous Improvement: Analyze downtime and process trends; implement improvements for reliability and efficiency.

Skills

Hands-on packaging equipment

GMP experience

Equipment verification

Technical writing

KNEAT/Veeva experience

Shift flexibility

Travel readiness

Education

Bachelor of Science in Engineering

Tools

KNEAT

Veeva

Job description

3 Key Consulting is seeking a Senior Process Development Engineer for a GMP packaging equipment program in New Albany, Ohio. This contract role requires hands-on support of highly automated packaging systems, CQV leadership, and cross-functional collaboration to drive process improvements.

Ideal candidates hold a B.S. in Engineering with 4+ years of GMP experience and are comfortable with 12-hour rotating shifts and up to 10% travel.