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.
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