Specialist Manufacturing Process Owner - Upstream / Downstream / Services (Biotechnology)

Location: Holly Springs, North Carolina, United States; onsite manufacturing plant role.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including products produced at its advanced FleXBatch drug substance manufacturing facility.

What you will do

• Own assigned upstream manufacturing, downstream manufacturing, or manufacturing services processes, equipment, and unit operations.
• Provide manufacturing floor support, troubleshooting, hypercare, startup assistance, and first-time execution support.
• Support operational readiness through water runs, dry runs, equipment verification, and Electronic Batch Record testing.
• Translate processes into SOPs, workflows, training materials, and digital manufacturing processes.
• Support change controls, risk assessments, root cause analyses, investigations, CAPA activities, and continuous improvement.
• Partner with Manufacturing Operations, Process Development, Supply Chain, Manufacturing, and Engineering on process transfers, material readiness, BOM alignment, MES/EBR activities, and inspection readiness.

Requirements

• Doctorate degree and 2 years of biotechnology operations experience, or master's degree and 4 years, bachelor's degree and 6 years, associate's degree and 10 years, or high school diploma/GED and 12 years of biotechnology operations experience.
• Technical expertise in upstream manufacturing, downstream manufacturing, or manufacturing services involving raw material dispensing and solution preparation.
• Strong knowledge of drug substance manufacturing processes, equipment, and unit operations.
• Experience in GMP biotechnology or pharmaceutical manufacturing, including floor operations, troubleshooting, operational readiness, and startup support.
• Experience authoring GMP documentation, supporting change controls, risk assessments, investigations, root cause analyses, and CAPA implementation.
• Experience with Manufacturing Execution Systems, Electronic Batch Records, single-use technologies, and Bill of Material structures.

Culture & Benefits

• Comprehensive benefits supporting professional and personal well-being.
• Career development opportunities and a collaborative work culture.
• Work within a global organization focused on biotechnology research, manufacturing, and patient care.
• Participation in an advanced facility combining disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.