Manufacturing Training Specialist Manufacturing Support - NC

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Holly Springs (NC)

On-site

USD 108,000 - 146,000

Full time

3 days ago

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Job summary

Amgen in Holly Springs, NC is seeking a Manufacturing Training Specialist 5 to lead training programs for ANC-1 and ANC-2 startups and ongoing operations. You will own qualification planning, TAP development, and LMS governance while coordinating with Manufacturing, Quality, Engineering, and Continuous Improvement teams to ensure readiness and strong GMP compliance.

The role emphasizes floor presence, cross‑functional leadership, and data‑driven decisions to sustain startup readiness and

Qualifications

Doctorate or Master’s in a relevant science or engineering field with biotech operations experience.
Experience in training development, facilitation, and SOP management.
Strong knowledge of GMP, training governance, and LMS systems.

Responsibilities

Develop and execute training strategy for ANC-1 and ANC-2 startups and ongoing manufacturing operations.
Own qualification planning, TAP development, and readiness governance.
Lead LMS-related migrations and cross-functional training initiatives.
Coach frontline leaders on GMP and operational excellence, and drive CAPAs to closure.
Partner with QA, Eng, Validation, Supply Chain, HR and Manufacturing for readiness milestones.

Skills

LMS knowledge

GMP compliance

Training development

Facilitation

Problem solving

Cross-functional collaboration

Project management

Data-driven decision making

Communication skills

Education

Doctorate degree

Master’s degree in chemistry, biology, or engineering

Bachelor’s degree + 5 years biotech ops

Associate’s degree + 10 years biotech ops

High school diploma + 12 years biotech ops

Tools

LMS

SOP editing

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience. Unless specifically stated otherwise, this role is "On‑Site" at the location detailed in the job post.

Manufacturing Training Specialist – Manufacturing Support

The Manufacturing Training Specialist 5 serves as a senior individual contributor within the Manufacturing Support organization, providing technical leadership and operational support to ensure safe, compliant, and efficient manufacturing training operations across the site, with clear accountability for manufacturing workforce readiness and startup readiness outcomes.

Reporting to the Senior Manager of the MFG Support technical training team, this role serves as a site subject matter expert for manufacturing training processes, training effectiveness, and continuous improvement programs.

The position requires significant floor presence and broad partnership with Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement teams to drive training readiness, operational performance, and quality improvement in a 24/7 manufacturing environment.

Organizational Impact

The Manufacturing Training Specialist 5 is a technical leader who strengthens manufacturing capability, enhances training effectiveness, and advances operational excellence across the organization. Through cross‑functional collaboration, ownership of qualification planning and execution, readiness metric governance, and leadership of training‑related CAPAs and continuous improvement initiatives, this role directly supports ANC‑1 and ANC‑2 startup readiness, operational readiness milestones, and the delivery of high‑quality medicines to patients.

Key Responsibilities

Training and Capability Development

Develop and execute the manufacturing training strategy for ANC-1 and ANC-2, ensuring alignment with business objectives, operational readiness requirements, compliance expectations, and workforce capability needs.
Create, implement, and continuously mature the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2 to establish role‑based qualification pathways, own qualification planning and execution, improve training effectiveness, and support sustainable operational performance.
Develop and maintain training and workforce readiness governance tools, metrics, and reporting processes to monitor training compliance, qualification status, staffing readiness, procedural readiness, and overall manufacturing startup readiness.
Identify readiness risks and gaps through metric review, stakeholder input, and floor engagement, then drive mitigation actions to protect operational readiness milestones, engineering runs, validation execution, and startup commitments.
Escalate and resolve issues when training, qualification, staffing, procedures, or other manufacturing readiness deliverables threaten startup milestones or operational readiness commitments.
Strengthen alignment between hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution to ensure the manufacturing workforce is prepared to support ANC-2 startup and routine operations.
Lead Manufacturing Fundamentals Training programs to support onboarding and qualification of new hires within the ANC-1 and ANC-2 organizations, ensuring consistent foundational knowledge and accelerated readiness.
Serve as the training lead for the 2027 Learning Management System (LMS) migration, partnering with cross‑functional stakeholders to support planning, implementation, change management, training impact assessments, and successful adoption of the new platform.
Lead training improvement initiatives across manufacturing operations.
Own and implement training‑related corrective and preventive actions (CAPAs), ensuring timely execution, effectiveness monitoring, and sustained compliance.
Assess training effectiveness and identify opportunities to strengthen workforce capability, procedural adherence, and operational performance.
Develop and deliver technical training programs, including the Wake Tech Customized Training Program, to improve employee knowledge, capability, and performance.
Coach manufacturing personnel and frontline leaders on GMP compliance, operational excellence practices, and manufacturing best practices.
Partner with Manufacturing, Quality, Engineering, and Continuous Improvement teams to establish and maintain training curricula that support process changes, operational excellence initiatives, and inspection readiness.

Manufacturing Floor Leadership

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 LMS and training-related processes in manufacturing.
Partner with operations teams to identify and implement training improvements that enhance safety, quality, delivery, and productivity.
Drive right-first-time execution through Human and Organizational Performance (HOP) tools and collection of operator feedback.

Cross-Functional Leadership

Partner effectively with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing teams to achieve site objectives and maintain integrated readiness plans that connect staffing, training, qualification, procedure readiness, engineering runs, and validation activities.
Influence stakeholders at multiple organizational levels to drive alignment, resolve issues, and implement sustainable solutions.
Serve as a key Manufacturing representative within ANC-2 Operational Readiness governance and planning activities, ensuring manufacturing workforce readiness, qualification execution, and startup risks are visible, aligned, 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.

Minimum Education Required

Masters

Additional Qualifications/Responsibilities

Basic Qualifications

Doctorate degree OR
Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or
Bachelor’s degree and 5 years of biotechnology operations experience or
Associate’s degree & 10 years of biotechnology operations experience or
High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications

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 the deviation management systems and corrective/preventative actions
Project management skills with ability to multi-task and function in a dynamic environment
Excellent communication skills and sense of urgency
Demonstrated ability to forge and maintain strong relationships
Strong knowledge of Learning Management Systems (LMS)

For a career that defies imagination. Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range