Manufacturing Training Specialist – Manufacturing Support (Biotechnology)

Location: On site in Holly Springs, North Carolina, United States

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

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including products at its FleX Batch drug substance manufacturing facility.

What you will do

• Develop and execute manufacturing training strategies for ANC-1 and ANC-2, including role-based qualification pathways through the Training Assignment Portfolio.
• Govern training, qualification, staffing, procedural, and manufacturing startup-readiness metrics, reporting, and mitigation plans.
• Lead Manufacturing Fundamentals Training, technical training programs, the 2027 Learning Management System migration, and training improvement initiatives.
• Own training-related corrective and preventive actions, assess training effectiveness, and support compliance, operational excellence, and inspection readiness.
• Provide floor-based coaching and technical assistance on GMP compliance, Human and Organizational Performance tools, manufacturing best practices, and right-first-time execution.
• Partner with Manufacturing, Quality, Engineering, Validation, Supply Chain, HR, and Continuous Improvement teams to align staffing, qualification, procedure, engineering-run, validation, and startup-readiness plans.

Requirements

• Doctorate degree, or a master’s degree in chemistry, biology, or engineering plus 3 years of biotechnology operations experience, or a bachelor’s degree plus 5 years of biotechnology operations experience, or an associate’s degree plus 10 years of biotechnology operations experience, or a high school diploma/GED plus 12 years of biotechnology operations experience.

Nice to have

• Hands-on experience facilitating problem solving in a biotechnology environment.
• Experience developing and facilitating training.
• Experience owning and editing standard operating procedures.
• Familiarity with deviation management systems and corrective/preventive actions.
• Project management skills, including multitasking in a dynamic environment.
• Excellent communication skills, a sense of urgency, and the ability to build and maintain strong relationships.
• Strong knowledge of Learning Management Systems.

Culture & Benefits

• On-site work in a 24/7 manufacturing environment with significant manufacturing-floor presence.
• Cross-functional collaboration across manufacturing, quality, engineering, validation, supply chain, HR, and continuous improvement.
• Work on a new drug substance manufacturing facility combining disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.
• Equal opportunity employment and reasonable accommodation are provided during the application, interview, and employment process.