GMP Method Engineer - Hybrid Role in Thousand Oaks

SSi People; Thousand Oaks (CA); Hybrid; USD 90,000 - 125,000; Full time

Job summary

SSI People is seeking an Engineer in Thousand Oaks, CA to contribute to the development, qualification, validation, and transfer of GMP physical test methods and related equipment. This role emphasizes cross-functional execution, thorough documentation, and proactive coordination across multiple projects.

You will develop and validate GMP test methods for vials, prefilled syringes, and injection devices, support method transfers to manufacturing, and help ensure projects stay on schedule and

Qualifications

• Develop and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Coordinate method transfers to manufacturing with six sigma processes and documentation.
• Support validation/qualification work and multi-project management.

Responsibilities

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Support the transfer of new combination product test methods and assembly requirements to manufacturing through six sigma processes and documentation.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods while helping ensure projects stay on schedule and within budget.
• Coordinate with internal teams and selected contractors, maintain integrated timelines, and communicate project status, risks, and mitigation options to leadership.

Skills

Solid Works

Technical writing

Statistics (Minitab)

Project management

Education

Master’s degree

Bachelor’s degree + 2 years

Associate’s degree + 6 years

High school diploma + 8 years

Tools

Minitab

Job description

SSI People is seeking an Engineer in Thousand Oaks, CA to contribute to the development, qualification, validation, and transfer of GMP physical test methods and related equipment. This role emphasizes cross-functional execution, thorough documentation, and proactive coordination across multiple projects.

You will develop and validate GMP test methods for vials, prefilled syringes, and injection devices, support method transfers to manufacturing, and help ensure projects stay on schedule and