Engineer (Biotechnology)

Location: Fully onsite in Thousand Oaks, California, United States; not eligible for remote or flexible work arrangements. Periodic on-call support during evenings, nights, and weekends is required.

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Support aseptic processing and sterile fill-finish manufacturing for clinical and commercial operations.
• Lead formulation, syringe and vial filling, process characterization, technology transfer, validation, and continuous process verification activities.
• Resolve process deviations and manufacturing issues through root cause analysis, risk assessments, and CAPA implementation.
• Provide real-time production-floor troubleshooting and implement improvements to increase reliability, agility, and efficiency.
• Introduce new drug product manufacturing technologies and support equipment requirements, FAT, process characterization, and validation for expansion projects.
• Collaborate with manufacturing, engineering, quality, drug product technology, and partner manufacturing sites on technical standards and best practices.

Requirements

• Master’s degree, or bachelor’s degree with 2 years of engineering experience, or associate degree with 6 years of engineering experience, or high school diploma/GED with 8 years of engineering experience.
• Preferred educational background in chemical engineering, biomedical engineering, biotechnology, life sciences, or a related technical field.
• Experience in pharmaceutical or biotechnology process development, process characterization, and technical transfers is preferred.
• Knowledge of freeze/thaw, formulation and mixing, filtration, filling, lyophilization, capping, visual inspection, quality systems, and GMP drug product manufacturing is preferred.
• Ability to independently design characterization studies, prepare technical protocols and reports, solve complex technical problems, and communicate technical concepts.
• Ability to work onsite in Thousand Oaks and provide periodic after-hours and weekend on-call support.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.