Principal Process Engineer (Upstream/Downstream)

Location: Holly Springs, North Carolina, United States; the role supports a physical drug substance manufacturing plant and includes up to 10% domestic and international travel.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Design, build, commission, qualify, and support manufacturing equipment and systems for drug substance production.
• Lead technical projects, design reviews, factory acceptance testing, installation, start-up, validation, and operational readiness activities.
• Own upstream and downstream process equipment and systems, providing end-to-end support for plant operations.
• Identify and implement equipment improvements, upgrades, modifications, and new product or technology introductions.
• Lead root-cause investigations, corrective and preventive actions, maintenance programs, and reliability improvements.
• Provide technical leadership, mentorship, cross-functional collaboration, and rotational on-call support for 24/7 operations.

Requirements

• Doctorate with 2 years of engineering experience; master's degree with 4 years; bachelor's degree with 6 years; associate's degree with 10 years; or high school diploma/GED with 12 years.
• At least 2 years of managerial experience or leadership experience directing teams, projects, programs, or resources.
• Experience in biopharmaceutical operations or manufacturing, preferably with process and plant engineering.
• Knowledge of upstream and downstream purification equipment, including cell culture reactors, centrifugation, chromatography, viral filtration, and UFDF skids.
• Experience with GMP environments, process design, technology transfer, commissioning and qualification, validation, change control, non-conformances, and corrective and preventive actions.
• Ability to support flexible schedules and 24/7 operations, communicate effectively, and travel domestically and internationally.

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, equipment troubleshooting, technical writing, and engineering or project leadership.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Opportunity to support a new drug substance manufacturing plant using disposable technologies, stainless steel equipment, and Industry 4.0 capabilities.
• Work focused on sustainable manufacturing, including reducing carbon emissions and waste.
• Rotational on-call support is required for continuous plant operations.