Senior Process Engineer (Biopharmaceutical Manufacturing)

Location: Holly Springs, North Carolina, United States; on-site support for a biopharmaceutical manufacturing plant, including rotational on-call coverage for 24/7 operations and approximately 10% domestic/international travel.

Company

hirify.global is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities with flexible production technologies, industry 4.0 capabilities, and sustainability initiatives.

What you will do

• Own biopharmaceutical process equipment and lead engineering improvements, upgrades, system design, construction support, startup, and validation.
• Design, build, commission, and qualify equipment and systems for downstream drug substance production.
• Collaborate with Manufacturing, Quality, Process Development, Maintenance, and engineering partners to ensure reliable plant operations.
• Develop maintenance programs, coordinate maintenance activities, and manage spare-parts availability.
• Lead technical root cause analysis, corrective and preventive actions, risk reduction, and downtime reduction.
• Support new product and technology introductions, engineering assessments, equipment modifications, engineering runs, audits, and regulatory inspections.

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's degree with 8 years; or a high school diploma/GED with 10 years of engineering experience.
• Bachelor's degree in Chemical or Mechanical Engineering preferred.
• 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing focused on downstream unit operations.
• Experience with GMP biopharmaceutical production equipment and systems, including cell culture reactors, centrifugation, chromatography, tangential flow filtration, autoclaves, CIP systems, washers, clean steam, and water for injection.
• Experience with GMP, OSHA, EPA, change control, non-conformances, CAPA, qualification, validation, capital projects, and regulated manufacturing environments.
• Ability to support flexible schedules, occasional after-hours engineering coverage, technical leadership, communication, teamwork, and approximately 10% domestic/international travel.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus program and stock-based long-term incentives.
• Paid time off plans and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.