Manufacturing Training Specialist – Manufacturing Support
Amgen
August 13, 2026
On-site
Holly Springs, NC
Operations
Manufacturing Training Specialist 5 – Manufacturing Support
Key Responsibilities
- Develop and execute the manufacturing training strategy for ANC-1 and ANC-2; create and mature the Training Assignment Portfolio (TAP) and qualification pathways.
- Maintain training/workforce readiness governance tools, metrics, and reporting for training compliance, qualification status, staffing readiness, procedural readiness, and startup readiness.
- Identify readiness risks/gaps and drive mitigations; escalate and resolve issues that threaten startup or operational readiness milestones.
- Strengthen alignment across hiring, qualification, readiness milestones, engineering runs, and validation execution to support ANC-2 startup and routine operations.
- Lead Manufacturing Fundamentals Training for onboarding/qualification; serve as training lead for the 2027 LMS migration (planning, implementation, change management, impact assessments, adoption).
- Lead training improvement initiatives; own training-related CAPAs and ensure effectiveness monitoring and sustained compliance.
- Assess training effectiveness; develop/deliver technical training (including Wake Tech Customized Training Program).
- Coach teams on GMP compliance, operational excellence, and best practices.
- Maintain strong manufacturing floor presence; act as SME for LMS/training processes.
- Drive right-first-time execution using Human and Organizational Performance (HOP) tools and operator feedback.
Cross-Functional Leadership
- Partner with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing to maintain integrated readiness plans and manage startup risks.
Basic Qualifications
- Doctorate OR Master’s (chemistry/biology/engineering) + 3 years biotech operations OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years.
Preferred Qualifications
- Facilitation of problem-solving; training development/facilitation; SOP ownership/editing.
- Deviation management and CAPA familiarity; project management; strong communication/urgency; relationship-building; LMS knowledge.
Application Instructions
- Apply now via careers.amgen.com for a career that defies imagination.
Key Responsibilities
- Develop and execute the manufacturing training strategy for ANC-1 and ANC-2; create and mature the Training Assignment Portfolio (TAP) and qualification pathways.
- Maintain training/workforce readiness governance tools, metrics, and reporting for training compliance, qualification status, staffing readiness, procedural readiness, and startup readiness.
- Identify readiness risks/gaps and drive mitigations; escalate and resolve issues that threaten startup or operational readiness milestones.
- Strengthen alignment across hiring, qualification, readiness milestones, engineering runs, and validation execution to support ANC-2 startup and routine operations.
- Lead Manufacturing Fundamentals Training for onboarding/qualification; serve as training lead for the 2027 LMS migration (planning, implementation, change management, impact assessments, adoption).
- Lead training improvement initiatives; own training-related CAPAs and ensure effectiveness monitoring and sustained compliance.
- Assess training effectiveness; develop/deliver technical training (including Wake Tech Customized Training Program).
- Coach teams on GMP compliance, operational excellence, and best practices.
- Maintain strong manufacturing floor presence; act as SME for LMS/training processes.
- Drive right-first-time execution using Human and Organizational Performance (HOP) tools and operator feedback.
Cross-Functional Leadership
- Partner with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing to maintain integrated readiness plans and manage startup risks.
Basic Qualifications
- Doctorate OR Master’s (chemistry/biology/engineering) + 3 years biotech operations OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years.
Preferred Qualifications
- Facilitation of problem-solving; training development/facilitation; SOP ownership/editing.
- Deviation management and CAPA familiarity; project management; strong communication/urgency; relationship-building; LMS knowledge.
Application Instructions
- Apply now via careers.amgen.com for a career that defies imagination.