Manufacturing Training Specialist – Manufacturing Support

Amgen•Holly Springs, NC

1d•$107,545 - $145,503

About The Position

The Manufacturing Training Specialist 5 is a senior individual contributor in the Manufacturing Support organization. The role provides technical leadership and operational support for safe, compliant, and efficient manufacturing training across the site, with accountability for workforce and startup readiness. Reporting to the Senior Manager of the MFG Support technical training team, the specialist serves as a site subject matter expert on manufacturing training processes, training effectiveness, and continuous improvement. The position requires significant manufacturing-floor presence and collaboration across Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement in a 24/7 manufacturing environment. The specialist develops training strategy and role-based qualification pathways for ANC-1 and ANC-2, owns qualification planning and execution, and governs workforce-readiness metrics and reporting. The role identifies and mitigates readiness risks, supports startup and operational readiness milestones, leads training improvement initiatives and training-related CAPAs, and builds workforce capability through training programs, coaching, and cross-functional partnership. It also serves as the training lead for the 2027 Learning Management System migration and as a key Manufacturing representative in ANC-2 operational-readiness governance.

Requirements

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

Nice To Haves

Hands-on experience facilitating problem solving in a biotechnology environment.
Experience with training development and facilitation.
Experience owning and editing standard operating procedures.
Familiarity with deviation management systems and corrective/preventive actions.
Project management skills, including the ability to multitask and function in a dynamic environment.
Excellent communication skills and a sense of urgency.
Demonstrated ability to forge and maintain strong relationships.
Strong knowledge of Learning Management Systems (LMS).

Responsibilities

Develop and execute the manufacturing training strategy for ANC-1 and ANC-2, aligned with business objectives, operational readiness requirements, compliance expectations, and workforce capability needs.
Create, implement, and continuously improve the Training Assignment Portfolio (TAP) and role-based qualification pathways for ANC-1 and ANC-2; own qualification planning and execution.
Develop and maintain training and workforce-readiness governance tools, metrics, and reporting processes covering compliance, qualification status, staffing, procedural readiness, and manufacturing startup readiness.
Identify readiness risks and gaps through metrics, stakeholder input, and floor engagement, and drive mitigation actions to protect readiness milestones, engineering runs, validation execution, and startup commitments.
Escalate and resolve issues when training, qualification, staffing, procedures, or other readiness deliverables threaten milestones or commitments.
Align hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution to prepare the workforce for ANC-2 startup and routine operations.
Lead Manufacturing Fundamentals Training programs for onboarding and qualification of ANC-1 and ANC-2 new hires.
Lead the training workstream for the 2027 Learning Management System migration, including planning, implementation, change management, training impact assessments, and adoption.
Lead training improvement initiatives across manufacturing operations.
Own and implement training-related corrective and preventive actions (CAPAs), including timely execution, effectiveness monitoring, and sustained compliance.
Assess training effectiveness and identify opportunities to improve workforce capability, procedural adherence, and operational performance.
Develop and deliver technical training programs, including the Wake Tech Customized Training Program.
Coach manufacturing personnel and frontline leaders on GMP compliance, operational excellence, and manufacturing best practices.
Partner with Manufacturing, Quality, Engineering, and Continuous Improvement to establish and maintain training curricula supporting process changes, operational excellence initiatives, and inspection readiness.
Maintain a strong presence on the manufacturing floor to provide training support, coaching, and technical assistance to frontline teams and leaders.
Serve as a subject matter expert for manufacturing LMS and training-related processes.
Partner with operations teams to identify and implement training improvements that enhance safety, quality, delivery, and productivity.
Drive right-first-time execution using Human and Organizational Performance (HOP) tools and operator feedback.
Partner with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing to maintain integrated readiness plans connecting staffing, training, qualification, procedure readiness, engineering runs, and validation activities.
Influence stakeholders across organizational levels to build alignment, resolve issues, and implement sustainable solutions.
Represent Manufacturing in ANC-2 Operational Readiness governance and planning, ensuring workforce readiness, qualification execution, and startup risks are visible and actively managed.
Provide data-driven recommendations, readiness-metric insights, and risk-based mitigation options to support business decisions, issue resolution, and operational-readiness governance.