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

Location: US - North Carolina - Holly Springs

Salary: $107,545.40–$145,502.60 per year

Company

hirify.global is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.

What you will do

• Own assigned upstream, downstream, or manufacturing services processes, equipment, and unit operations.
• Provide manufacturing floor support, troubleshooting, hypercare, and technical input during routine operations, process changes, startup, and first-time executions.
• Support operational readiness activities, including water and dry runs, equipment readiness verification, and EBR testing.
• Partner with Manufacturing Operations, Process Development, Supply Chain, and Engineering on process execution, knowledge transfer, material readiness, and BOM alignment.
• Author and maintain GMP SOPs, forms, workflows, training materials, and digital manufacturing processes.
• Support change controls, risk assessments, investigations, root cause analyses, CAPA activities, audits, and continuous improvement initiatives.

Requirements

• Doctorate and 2 years of biotechnology operations experience; or master's degree in a relevant field and 4 years; or bachelor's degree and 6 years; or associate's degree and 10 years; or high school diploma/GED and 12 years.
• Technical knowledge of drug substance manufacturing processes, equipment, and unit operations.
• Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.
• Experience with manufacturing floor operations, troubleshooting, operational readiness, startup support, and GMP documentation.
• Experience with change controls, risk assessments, investigations, root cause analysis, and CAPA activities.
• Experience supporting MES and Electronic Batch Records in a GMP manufacturing environment.

Nice to have

• Expertise in upstream manufacturing, downstream manufacturing, or raw material dispensing and solution preparation.
• Knowledge of single-use technologies and Bill of Material structures.
• Strong technical writing, communication, problem-solving, and organizational skills.

Culture & Benefits

• Comprehensive benefits supporting professional and personal well-being.
• Career development opportunities.
• Collaborative culture focused on serving patients.