Engineer

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

Job Title: Engineer
Location: Thousand Oaks, California (Hybrid)
Job Summary: We are supporting an opportunity for an Engineer to contribute to the development, qualification, validation, and transfer of physical GMP test methods and related equipment. Our team is seeking a candidate who can help drive cross‑functional execution, strong documentation, and effective coordination across multiple projects.

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.

Required

• Master’s degree, or Bachelor’s degree with 2 years of engineering/scientific experience, or Associate’s degree with 6 years of engineering/scientific experience, or high school diploma/GED with 8 years of engineering/scientific experience.
• Solid Works experience.
• Technical writing skills.
• Statistics experience, including experience utilizing Minitab or other statistical software packages.
• Experience with validation or qualification work and the ability to manage multiple projects.
• Preferred experience includes combination products, regulatory requirements, biotechnology/pharmaceutical industry experience, and equipment, method, or mechanical design.

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long‑term relationships, not transactions. Putting people first is just what we do well.