Manufacturing Training Specialist – Manufacturing Support

Amgen•Holly Springs, NC

17h

About The Position

The Manufacturing Training Specialist 5 is a senior individual contributor in the Manufacturing Support organization, providing technical leadership and operational support for safe, compliant, and efficient manufacturing training. The role is accountable for manufacturing workforce readiness and startup readiness outcomes and serves as the site subject matter expert for manufacturing training processes, training effectiveness, and continuous improvement. It reports to the Senior Manager of the MFG Support technical training team and requires substantial manufacturing-floor presence and broad cross-functional partnership in a 24/7 manufacturing environment. The position develops and executes the manufacturing training strategy for ANC-1 and ANC-2, owns qualification planning and execution, and governs tools and metrics for training, workforce, and startup readiness. It identifies readiness risks and drives mitigation and escalation to protect operational milestones, engineering runs, validation execution, and startup commitments. The role also leads foundational training, training improvements and CAPAs, and serves as training lead for the 2027 LMS migration. It coaches employees and frontline leaders, supports right-first-time execution, and represents Manufacturing in ANC-2 operational readiness governance. The role supports Amgen’s FleX Batch drug substance manufacturing facility, which is described as combining disposable technologies with stainless-steel equipment and embedded Industry 4.0 capabilities. The facility’s sustainability innovations are intended to reduce carbon and waste as part of Amgen’s plan to become carbon-neutral by 2027.

Requirements

Doctorate degree, or a master’s degree in chemistry, biology, or engineering and 3 years of biotechnology operations experience.
Alternatively, a bachelor’s degree and 5 years of biotechnology operations experience.
Alternatively, an associate degree and 10 years of biotechnology operations experience.
Alternatively, a high school diploma or 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 in alignment with business objectives, operational readiness, compliance expectations, and workforce capability needs.
Create, implement, and mature the Training Assignment Portfolio (TAP), establishing role-based qualification pathways and owning qualification planning and execution.
Develop and maintain training and workforce readiness governance tools, metrics, and reporting processes covering training compliance, qualification status, staffing readiness, procedural readiness, and manufacturing startup readiness.
Identify readiness risks and gaps through metric review, stakeholder input, and floor engagement; 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 manufacturing training improvement initiatives and own training-related CAPAs, ensuring 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 teams to establish and maintain curricula supporting process changes, operational excellence initiatives, and inspection readiness.
Maintain a strong manufacturing-floor presence 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 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 drive 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 for business decisions, issue resolution, and operational readiness governance.