Physical Methods Development Engineer : 26-03293

Akraya Inc.; 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

Primary Skills: SolidWorks (advanced), Statistical Analysis (intermediate), Technical Writing (intermediate), GMP Test Method Development (advanced), Combination Product/Medical Device/Drug Delivery Device Development (intermediate) Contract Type: W2 Contract Duration: 24+ Months Location: Thousand Oaks, CA (3 days a week onsite minimum) Pay Range: $38.00 - $43.00 Per Hour

Job Summary: This role involves developing, qualifying, and validating physical test methods for critical pharmaceutical products. The engineer will work on multiple projects, driving improvements in quality, reliability, and cost reduction through new product and process introductions. Key activities include expert support for method lifecycle, manufacturing transfer, and production support.

Key Responsibilities

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

Must-Have Skills

• Proficiency in SolidWorks or similar 3D CAD software.
• Experience with statistical analysis tools like Minitab.
• Demonstrated technical writing capabilities.
• Experience in the biotechnology or pharmaceutical industry is preferred, with a focus on developing and validating physical test methods for combination products.

About Akraya

Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment.