обновлено 14 дней назад
Manufacturing Training Specialist – Manufacturing Support (Biotechnology Manufacturing)
107 545 - 145 503$
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Описание вакансии
Текст:
TL;DR
Manufacturing Training Specialist – Manufacturing Support (Biotechnology Manufacturing): Developing and leading training, qualification, and workforce-readiness programs for advanced drug-substance manufacturing operations with an accent on GMP compliance, startup readiness, and training effectiveness. Focus on governing qualification plans, supporting ANC-1 and ANC-2 startup activities, leading the LMS migration, and driving CAPAs and continuous improvement across a 24/7 manufacturing environment.
Location: Holly Springs, North Carolina, United States; significant manufacturing-floor presence required in a 24/7 manufacturing environment.
Salary: $107,545.40–$145,502.60 per year
Company
is a biotechnology company developing and manufacturing medicines, including products at its advanced 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 and workforce-readiness plans.
- Build and maintain training governance tools, readiness metrics, reporting processes, and mitigation plans for startup and operational milestones.
- Lead Manufacturing Fundamentals Training and technical training programs, including the Wake Tech Customized Training Program.
- Serve as training lead for the 2027 Learning Management System migration, including implementation, change management, impact assessment, and adoption.
- Own training-related CAPAs and lead initiatives that improve training effectiveness, procedural adherence, safety, quality, delivery, and productivity.
- Coach manufacturing personnel and frontline leaders while partnering with Quality, Engineering, Validation, Supply Chain, HR, and Continuous Improvement.
Requirements
- Doctorate degree, or a relevant master’s degree plus 3 years of biotechnology operations experience.
- Bachelor’s degree plus 5 years of biotechnology operations experience, or an associate’s degree plus 10 years of experience.
- High school diploma or GED plus 12 years of biotechnology operations experience.
- Experience developing and facilitating training, editing standard operating procedures, and working with deviation management and CAPA systems.
- Strong knowledge of Learning Management Systems, project management, communication, and stakeholder relationship-building.
- Ability to provide floor-based training support and lead readiness activities in a dynamic manufacturing environment.
Culture & Benefits
- Work alongside cross-functional manufacturing, quality, engineering, supply chain, HR, and continuous improvement professionals.
- Support a new facility combining disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.
- Contribute to the production of high-quality medicines and operational readiness for a 24/7 manufacturing site.
- provides reasonable accommodation during the application and employment process.
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