Senior Process Engineer - Solution Prep, Upstream, and Downstream (Biopharmaceutical Manufacturing)

Location: On-site in Holly Springs, North Carolina, with up to 10% domestic and international travel

Company

hirify.global develops, manufactures, and delivers biotechnology medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Design, build, commission, qualify, and validate equipment and systems for drug-substance production.
• Support equipment design reviews, factory acceptance testing, installation, start-up, engineering qualification, and performance qualification.
• Own solution preparation, upstream, and downstream process equipment and provide end-to-end operational support.
• Lead equipment improvements, upgrades, new product introductions, engineering assessments, and risk remediation.
• Develop maintenance programs, coordinate spare parts and maintenance activities, and reduce production downtime through root-cause analysis and corrective actions.
• Collaborate with Manufacturing, Quality, Process Development, Maintenance, equipment manufacturers, and network partners while supporting audits and 24/7 operations.

Requirements

• Doctorate degree; or a master's degree with 2 years of engineering experience; or a bachelor's degree with 4 years; or an associate degree with 8 years; or a high school diploma/GED with 10 years of engineering experience.
• Degree in Chemical Engineering, Mechanical Engineering, or a similar discipline.
• 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing.
• Direct experience with solution preparation, upstream, and downstream equipment, including reactors, centrifuges, chromatography, viral filtration, UF/DF, CIP, autoclaves, clean steam, and water-for-injection systems.
• Experience with technology transfer, process design, commissioning and qualification, and regulated environments such as cGMP, OSHA, and EPA.
• Strong technical writing, communication, facilitation, teamwork, problem-solving, leadership, schedule flexibility, and ability to support 24/7 operations.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Work on a new drug-substance manufacturing facility using disposable technologies, stainless steel equipment, and embedded Industry 4.0 capabilities.
• Competitive benefits and comprehensive total rewards aligned with local industry standards.
• Inclusive workplace focused on professional growth, well-being, and advancing science to serve patients.