Manufacturing Training Specialist Manufacturing Support - NC

VetJobs•Holly Springs, NC

1d•$107,545 - $145,503•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 operations. The role is accountable for manufacturing workforce readiness and startup readiness outcomes across the site. Reporting to the Senior Manager of the MFG Support technical training team, the specialist acts as a site subject matter expert in manufacturing training processes, training effectiveness, and continuous improvement. The position requires substantial manufacturing-floor presence and extensive collaboration across Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement in a 24/7 manufacturing environment. The role strengthens manufacturing capability and operational excellence through qualification planning and execution, readiness metric governance, training-related CAPAs, and continuous improvement initiatives. It supports ANC-1 and ANC-2 startup readiness and operational readiness milestones, helping ensure delivery of 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's 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 work 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 requirements, compliance expectations, and workforce capability needs.
Create, implement, and continuously improve the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2, including role-based qualification pathways, qualification planning and execution, and improvements to training effectiveness.
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 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 startup milestones or operational readiness 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 to onboard and qualify new hires in ANC-1 and ANC-2.
Serve as the training lead for the 2027 Learning Management System (LMS) migration, supporting 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 practices, 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 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 achieve site objectives and maintain integrated readiness plans linking 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, aligned, and managed.
Provide data-driven recommendations, readiness metric insights, and risk-based mitigation options for business decisions, issue resolution, and operational readiness governance.