Manufacturing Training Specialist Manufacturing Support (Biotechnology)

Location: Holly Springs, North Carolina, United States; significant manufacturing-floor presence is required in a 24/7 manufacturing environment.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including operations at the FleXBatch drug substance manufacturing facility.

What you will do

• Develop and execute the manufacturing training strategy for ANC-1 and ANC-2 startup and routine operations.
• Create and manage role-based qualification pathways through the Training Assignment Portfolio.
• Govern training, qualification, staffing, procedural, and manufacturing readiness metrics and reporting.
• Identify and mitigate readiness risks affecting engineering runs, validation execution, and startup milestones.
• Lead Manufacturing Fundamentals Training, technical training programs, and the 2027 LMS migration.
• Own training-related CAPAs and improvement initiatives while coaching frontline personnel on GMP and operational excellence.

Requirements

• Doctorate degree; or a master's degree in chemistry, biology, or engineering plus 3 years of biotechnology operations experience.
• Bachelor's degree plus 5 years of biotechnology operations experience; alternatively, an associate's degree plus 10 years or a high school diploma/GED plus 12 years of experience.
• Experience developing and facilitating training programs in a biotechnology or manufacturing environment.
• Experience with standard operating procedures, deviation management systems, and corrective and preventive actions.
• Strong knowledge of Learning Management Systems and the ability to manage projects in a dynamic environment.
• Strong communication, relationship-building, problem-solving, and issue-escalation skills.

Nice to have

• Experience facilitating hands-on problem solving in a biotechnology environment.
• Experience delivering the Wake Tech Customized Training Program.

Culture & Benefits

• Work alongside cross-functional Manufacturing, Quality, Engineering, Validation, Supply Chain, HR, and Continuous Improvement teams.
• Support a new manufacturing facility using disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.
• Contribute to hirify.global's goal of becoming carbon neutral by 2027.
• Work in a role with direct impact on manufacturing workforce readiness and delivery of medicines to patients.