Pharma GMP Methods Engineer — SolidWorks & QC Impact

Akraya; Thousand Oaks (CA); On-site; USD 52,000 - 59,000; Full time

Job summary

Akraya is seeking an engineer to develop, qualify, and validate GMP physical test methods for critical pharmaceutical products in Thousand Oaks, CA. You will drive improvements in quality, reliability, and cost reduction through new product and process introductions.

The role involves expert support for method lifecycle, manufacturing transfer, and production support on multiple projects. Prior pharma/biotech test method development experience is preferred, with on-site collaboration three days

Qualifications

• Proficiency in SolidWorks or similar 3D CAD software.
• Experience with statistical analysis tools like Minitab.
• Demonstrated technical writing capabilities.
• Experience in biotechnology/pharmaceutical industry, focusing on test method development/validation.

Responsibilities

• Design and validate GMP physical test methods for pharmaceutical components.
• Collaborate on transferring new product test methods to manufacturing.
• Develop and validate equipment, software, systems, and testing methodologies.
• Manage projects to ensure timely and budget-conscious completion.
• Coordinate test method development activities with external contractors.

Skills

SolidWorks

Statistical Analysis

Technical Writing

GMP Test Method Development

Combination Product/Medical Device/PhD

Tools

Minitab

Job description

Akraya is seeking an engineer to develop, qualify, and validate GMP physical test methods for critical pharmaceutical products in Thousand Oaks, CA. You will drive improvements in quality, reliability, and cost reduction through new product and process introductions.

The role involves expert support for method lifecycle, manufacturing transfer, and production support on multiple projects. Prior pharma/biotech test method development experience is preferred, with on-site collaboration three days