GMP Physical Test Method Engineer – Combination Products

3key Consulting, Inc.; Thousand Oaks (CA); Hybrid; USD 58,000 - 63,000; Part time

Job summary

3key Consulting, Inc. seeks an Engineer for GMP physical test method development & validation in Thousand Oaks, CA. The contract role involves developing and validating methods for combination products, transferring to manufacturing, and supporting life cycle of testing processes.

The ideal candidate has a BS with 2+ years in engineering, strong SolidWorks skills, solid writing abilities, and statistical analysis experience. Hybrid onsite work in Thousand Oaks is required.

Qualifications

• Bachelor's degree (or higher) with 2+ years engineering experience or equivalent.
• SolidWorks proficiency and experience with statistical analysis.
• Strong technical writing skills and documentation ability.

Responsibilities

• Develop, qualify, and validate GMP physical test methods for combination products.
• Transfer methods to manufacturing and compile documentation for assemblies.
• Lead cross-functional projects ensuring scope, budget, and timelines.
• Coordinate test method development with contractors and internal teams.
• Generate procedures to support new processes and equipment validation.

Skills

SolidWorks

Technical Writing

Statistics

Education

Master's Degree

Bachelor's Degree + 2 years

Associate's degree + 6 years

High school diploma/GED + 8 years

Tools

Minitab

CAD software

Job description

3key Consulting, Inc. seeks an Engineer for GMP physical test method development & validation in Thousand Oaks, CA. The contract role involves developing and validating methods for combination products, transferring to manufacturing, and supporting life cycle of testing processes.

The ideal candidate has a BS with 2+ years in engineering, strong SolidWorks skills, solid writing abilities, and statistical analysis experience. Hybrid onsite work in Thousand Oaks is required.