Principal Engineer (Biotechnology)

Location: On-site in Thousand Oaks, California, United States; up to 10% domestic and international travel required.

Annual salary: $140,334.15–$189,863.85.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across biologic and pharmaceutical therapeutic areas.

What you will do

• Lead the design and execution of process development for aseptic filling, lyophilization, and manual or automated visual inspection.
• Develop and standardize tools, protocols, reports, and study approaches that improve process efficiency and platform harmonization.
• Collaborate with manufacturing, quality, regulatory, and technical subject matter experts on process characterization, recipe development, and technology transfers.
• Support clinical and commercial manufacturing through process capability analysis, troubleshooting, root-cause analysis, and product impact assessments.
• Use advanced statistical and analytical techniques, statistical software, and in silico modeling tools to support data-driven decisions.
• Prepare technical documentation, regulatory sections, progress reports, presentations, manuscripts, and technical articles.

Requirements

• Doctorate degree and 2 years, master’s degree and 4 years, bachelor’s degree and 6 years, associate’s degree and 10 years, or high school diploma/GED and 12 years of engineering or operations experience.
• Advanced degree in engineering, biotechnology, pharmaceutics, or a related discipline, with experience in pharmaceutical development and manufacturing.
• Experience with drug product unit operations, including formulation, filtration, filling, lyophilization, capping, freeze/thaw, and visual inspection.
• Experience with process characterization, validation, statistical process control, design and analysis of experiments, and statistical software such as JMP or Minitab.
• Experience with process technology transfer, aseptic processing, equipment design, digital process control, automation, and global manufacturing sites.
• Familiarity with FDA/EU GMP standards, global regulatory requirements, cross-functional leadership, and project management.

Nice to have

• Experience using Artificial Intelligence and Generative AI tools for automation, data analysis, workflow optimization, or AI-powered operational solutions.
• Experience developing recipes with offline pilot capabilities or in a manufacturing 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 program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.