Senior CQV Engineer, Combo Products & Packaging

3key Consulting, Inc.; New Albany (OH); On-site; USD 76,000 - 87,000; Full time

Job summary

3Key Consulting, Inc. is seeking a Senior CQV Validation Engineer for a challenging contract engagement with a leading biopharmaceutical company in New Albany, OH.

The role focuses on validation of combination products, packaging manufacturing, and device assembly, with day-to-day support of GMP operations and CQV activities. You will lead commissioning, qualification, and validation efforts, develop CQV protocols, and collaborate across Manufacturing, Quality, and Validation teams to ensure

Qualifications

• Demonstrated CQV leadership in GMP biotech/pharma environments.
• Experience authoring CQV protocols and technical reports.

Responsibilities

• Lead commissioning, qualification, and validation activities for packaging and combination product processes.
• Develop and execute validation protocols and technical reports to support commercial manufacturing.

Skills

CQV leadership

GMP manufacturing

QA systems experience

onsite/off-shift

Education

Doctorate

Masters

Bachelors

Associates

High school diploma

Tools

KNEAT

Veeva

TrackWise

Job description

3Key Consulting, Inc. is seeking a Senior CQV Validation Engineer for a challenging contract engagement with a leading biopharmaceutical company in New Albany, OH.

The role focuses on validation of combination products, packaging manufacturing, and device assembly, with day-to-day support of GMP operations and CQV activities. You will lead commissioning, qualification, and validation efforts, develop CQV protocols, and collaborate across Manufacturing, Quality, and Validation teams to ensure