Process Engineer (Biopharmaceutical Manufacturing)

Location: On-site in Holly Springs, North Carolina, United States; up to 10% domestic and international travel, with rotational on-call or shift support for 24/7 operations.

Company

hirify.global is a biotechnology company developing, 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 equipment and systems for drug substance production.
• Support manufacturing system commissioning and qualification in alignment with GMP requirements and interact with regulatory inspectors.
• Assess and implement equipment or facility system modifications, new technologies, and engineering improvements.
• Develop maintenance programs, manage spare-parts availability, and coordinate maintenance activities.
• Identify performance risks, perform technical root cause analysis, and implement corrective and preventive actions to reduce downtime.
• Support construction, start-up, validation, engineering runs, and operational readiness for capital projects.

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.
• Bachelor’s degree in chemical, mechanical, or a similar engineering discipline preferred.
• 3+ years of relevant experience, including 2+ years in biopharmaceutical operations or manufacturing.
• Direct experience with GMP biopharmaceutical production equipment, including solution preparation, cell culture, centrifugation, chromatography, viral filtration, and UFDF systems.
• Experience with regulated environments and GMP quality systems, including change control, non-conformances, CAPA, qualification, and validation.
• Flexibility to support 24/7 operations, occasional after-hours engineering coverage, and domestic or international travel.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Opportunity to contribute to a new drug substance manufacturing facility using disposable technologies, stainless steel equipment, and 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 for patients.