Engineer - Physical Methods (Biotech)

Location: On site in Thousand Oaks, California, United States; approximately 10% travel, including international travel.

Salary: $88,281–$119,439 annually.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses.

What you will do

• Develop, qualify, validate, and transfer GMP physical test methods for vials, prefilled syringes, injection devices, combination products, devices, and packaging components.
• Design test concepts, tooling, fixtures, prototypes, equipment, software, and systems, including feasibility, robustness, and equipment qualification activities.
• Transfer test methods and assembly requirements to manufacturing while developing Six Sigma processes and supporting new process and equipment introductions.
• Author and maintain test method documents, procedures, timelines, cost estimates, and capital request documentation.
• Provide expert support for investigations, CAPAs, change controls, continuous improvement, and lifecycle management of production methods.
• Coordinate contractors and collaborate with manufacturing, quality, regulatory, engineering, and other cross-functional partners.

Requirements

• Master’s degree, or bachelor’s degree plus 2 years of engineering experience, or associate’s degree plus 6 years of engineering experience, or high school diploma/GED plus 8 years of engineering experience.
• Experience in equipment, test method, and mechanical design; biotechnology or pharmaceutical industry experience is preferred.
• Experience with combination products and regulatory requirements is preferred.
• Experience with SolidWorks or other 3D CAD software, Minitab or statistical software, machine controls such as PLC/HMI, and vision systems is preferred.
• Strong written and verbal communication skills and the ability to work in a highly matrixed environment.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and paid time off.
• Career development and work-life balance support.