2 дня назад
Manufacturing Training Specialist Manufacturing Support (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Training Specialist Manufacturing Support (Biotechnology): Developing and executing training and qualification programs for the ANC-1 and ANC-2 drug-substance manufacturing organizations with an accent on workforce readiness, compliance, and startup execution. Focus on governing readiness metrics, leading LMS migration and training-related CAPAs, and solving qualification and operational readiness risks in a 24/7 manufacturing environment.
Location: Holly Springs, North Carolina, United States; onsite role with significant manufacturing floor presence in a 24/7 manufacturing environment
Company
is a biotechnology company developing and manufacturing medicines for patients worldwide.
What you will do
- Develop and execute the manufacturing training strategy for the ANC-1 and ANC-2 organizations.
- Create and maintain role-based qualification pathways, readiness governance tools, metrics, and reporting.
- Identify and mitigate training, staffing, qualification, procedure, and startup-readiness risks.
- Lead Manufacturing Fundamentals Training, technical training programs, and the 2027 Learning Management System migration.
- Own training-related corrective and preventive actions, assess training effectiveness, and lead continuous improvement initiatives.
- Coach manufacturing personnel and frontline leaders while partnering with Manufacturing, Quality, Engineering, Validation, Supply Chain, HR, and Continuous Improvement teams.
Requirements
- Doctorate degree, or a master's degree in chemistry, biology, or engineering with 3 years of biotechnology operations experience.
- Bachelor's degree with 5 years of biotechnology operations experience, or an associate's degree with 10 years of experience.
- High school diploma or GED with 12 years of biotechnology operations experience.
- Experience with training development and facilitation, standard operating procedures, and deviation or CAPA systems.
- Strong knowledge of Learning Management Systems, project management, communication, and stakeholder relationship-building.
- Ability to work onsite with regular manufacturing floor presence in Holly Springs, North Carolina.
Culture & Benefits
- Work in a new drug-substance manufacturing facility combining disposable technologies, stainless-steel equipment, and industry 4.0 capabilities.
- Collaborate in a cross-functional environment focused on safety, quality, delivery, productivity, and operational excellence.
- Support sustainability initiatives designed to reduce carbon emissions and waste.
- Participate in a mission-driven biotechnology organization serving patients worldwide.
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