Principal Process Engineer (Biopharmaceutical Manufacturing)

Location: Holly Springs, North Carolina, United States; up to 10% domestic and international travel; schedule flexibility required to support 24/7 operations.

Salary: $140,334.15–$189,863.85 USD annually

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses.

What you will do

• Design, build, commission, qualify, and support manufacturing equipment and systems for drug substance production.
• Lead technical projects, engineering assessments, equipment modifications, and new product or technology introductions.
• Own upstream and downstream process equipment, areas, and systems across their operational lifecycle.
• Collaborate with Manufacturing, Quality, Process Development, Maintenance, network partners, and equipment manufacturers.
• Develop maintenance programs, support spare-parts availability, and improve equipment reliability and production uptime.
• Lead root-cause investigations, corrective and preventive actions, audits, and technical problem-solving for 24/7 operations.

Requirements

• Doctorate with 2 years of engineering experience, Master’s with 4 years, Bachelor’s with 6 years, Associate’s with 10 years, or high school diploma/GED with 12 years of engineering experience.
• At least 2 years of managerial or leadership experience managing people, teams, projects, programs, or resources.
• Relevant experience in biopharmaceutical operations or manufacturing, including process and plant engineering.
• Direct experience with upstream and downstream equipment such as cell culture reactors, centrifuges, chromatography, viral filtration, and UFDF skids.
• Experience with GMP environments, process design, technology transfer, commissioning and qualification, validation, change control, deviations, and corrective and preventive actions.
• Strong technical writing, communication, leadership, facilitation, and teamwork skills.

Nice to have

• Bachelor’s degree in Chemical or Mechanical Engineering or a related technical field.
• Eight or more years of relevant experience, including five or more years in biopharmaceutical manufacturing.
• Experience with automation systems, CIP systems, autoclaves, washers, clean steam, and water-for-injection systems.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Opportunity to support a new drug substance manufacturing plant using disposable technologies, stainless steel equipment, and Industry 4.0 capabilities.
• Work includes rotational on-call support for continuous plant operations.
• Role supports sustainability initiatives designed to reduce carbon emissions and waste.