Senior GMP Validation Engineer – Lab Equipment

3key Consulting, Inc.; Kansas; On-site; USD 56,000 - 63,000; Full time

Job summary

3key Consulting is hiring a Senior Validation Engineer for GMP Laboratory Equipment Qualification & Inspection Systems in Cambridge, MA. The role supports the Combination Product Operations MS&T - Physical Sciences and Engineering, focusing on validation methods, equipment qualification, and lifecycle documentation.

The ideal candidate has a 3+ years background in regulated environments, GMP exposure, experience with test method development, CAD/SolidWorks, and data analytics.

Qualifications

• Experience in regulated industry; GMP exposure preferred.
• Hands-on lab experience and ability to generate technical documentation.
• Experience with test method development and data analysis.

Responsibilities

• Develop and support lifecycle management of physical test methods and related documentation.
• Execute test method protocols and analyze data.
• Maintain project status and communicate with internal clients at Amgen.

Skills

Verbal communication

Project management

Statistics

Gage R&R

Education

Bachelor's degree in engineering or science

Master's degree (preferred)

Tools

CAD design

SolidWorks

Job description

3key Consulting is hiring a Senior Validation Engineer for GMP Laboratory Equipment Qualification & Inspection Systems in Cambridge, MA. The role supports the Combination Product Operations MS&T - Physical Sciences and Engineering, focusing on validation methods, equipment qualification, and lifecycle documentation.

The ideal candidate has a 3+ years background in regulated environments, GMP exposure, experience with test method development, CAD/SolidWorks, and data analytics.