Manufacturing Training Specialist Manufacturing Support - NC

Military Spouse Corporate Career Network•Holly Springs, NC

11h•Onsite

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 workforce and startup readiness across the site and serves as a subject matter expert on manufacturing training processes, effectiveness, and continuous improvement. It reports to the Senior Manager of the MFG Support technical training team and requires substantial manufacturing-floor presence and collaboration with Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement teams in a 24/7 manufacturing environment. The position leads training strategy and qualification planning for ANC-1 and ANC-2, develops workforce-readiness governance and metrics, identifies and mitigates readiness risks, and supports startup milestones, engineering runs, validation execution, and routine operations. It also leads Manufacturing Fundamentals Training, serves as training lead for the 2027 LMS migration, owns training-related CAPAs and improvement initiatives, and develops and delivers technical training, including the Wake Tech Customized Training Program. The specialist coaches manufacturing personnel and frontline leaders on GMP compliance, operational excellence, and manufacturing best practices. As a key Manufacturing representative in ANC-2 Operational Readiness governance, the role provides data-driven insights and risk-based recommendations to help achieve integrated readiness and deliver high-quality medicines.

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, compliance, and workforce capability needs.
Create, implement, and mature the Training Assignment Portfolio (TAP), including role-based qualification pathways and qualification planning and execution.
Develop and maintain training and workforce-readiness governance tools, metrics, and reporting processes.
Identify training, qualification, staffing, procedural, and other readiness risks; drive mitigation and escalate or resolve issues that threaten readiness commitments.
Align hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution.
Lead Manufacturing Fundamentals Training for onboarding and qualification of new hires in ANC-1 and ANC-2.
Lead the training workstream for the 2027 LMS migration, including planning, implementation, change management, training impact assessments, and adoption.
Lead manufacturing training improvement initiatives and own training-related CAPAs, including timely execution and effectiveness monitoring.
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 training curricula supporting process changes, operational excellence, and inspection readiness.
Maintain a strong manufacturing-floor presence to provide training support, coaching, and technical assistance.
Serve as a subject matter expert for LMS and manufacturing training 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.
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 readiness insights and risk-based mitigation recommendations for business decisions and operational-readiness governance.