GMP Test Method Engineer – Validation & Data Analysis

3key Consulting, Inc.; Massachusetts; On-site; USD 56,000 - 63,000; Part time

Job summary

3key Consulting, Inc. in Cambridge, MA is seeking an Engineer – GMP Test Methods Development & Validation for a 2+ year contract with potential extensions.

The role focuses on development, validation, and lifecycle management of physical test methods and associated equipment within a regulated biopharmaceutical setting. The ideal candidate will have strong engineering fundamentals, experience with validation (IQ/OQ/PQ), data analysis, and the ability to produce well-documented results.

Qualifications

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Experience in regulated industry and GMPs preferred
• Excellent verbal and written communication skills to communicate project status and risks to leadership
• Willingness to work onsite in Cambridge, MA

Responsibilities

• Develop and support lifecycle management of physical GMP test methods and associated documentation (test method protocols, SOPs, training documents, etc.)
• Execute test method protocols, analyze data
• Maintain projects status and communicate with companyinternal clients

Skills

Strong communication

Project management

Data analysis

Education

Master's or Bachelor's with experience

Tools

CAD

SolidWorks

Job description

3key Consulting, Inc. in Cambridge, MA is seeking an Engineer – GMP Test Methods Development & Validation for a 2+ year contract with potential extensions.

The role focuses on development, validation, and lifecycle management of physical test methods and associated equipment within a regulated biopharmaceutical setting. The ideal candidate will have strong engineering fundamentals, experience with validation (IQ/OQ/PQ), data analysis, and the ability to produce well-documented results.