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 ownershipof qualification planning and execution readiness metric governance and leadership of training-related CAPAs and continuous improvement initiatives this role directly supportsANC-1 and ANC-2 startup readiness operational readiness milestones andthe 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 businessobjectives 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 toestablishrole-based qualification pathwaysown qualification planning and executionimprove training effectiveness and support sustainable operational performance.

• Develop andmaintaintrainingand workforcereadiness governance tools metrics and reporting processes tomonitortraining compliance qualification statusstaffing readiness procedural readiness and overall manufacturing startupreadiness.

• Identifyreadiness 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) ensuringtimelyexecution effectiveness monitoring and sustained compliance.

• Assess training effectiveness andidentifyopportunities 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 toestablishand 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 providetrainingsupport coaching andtechnicalassistanceto frontline teams and leaders.

• Serve as a subject matter expert for LMS and training-related processes in manufacturing.

• Partner with operations teams toidentifyand implementtrainingimprovements that enhance safety quality delivery and productivity.

• Drive right-first-time execution throughHuman and Organizational Performance (HOP) toolsand collection of operator feedback.

Cross-Functional Leadership

• Partner effectively with Quality Engineering Validation Supply ChainHRand Manufacturing teams to achieve siteobjectivesandmaintainintegrated 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 optionsto support business decisions issue resolutionand operationalreadiness governance.

Basic Qualifications:

• Doctorate degree OR

• Masters degree in chemistry biologyor engineering & 3 years of biotechnology operations experience or

• Bachelors degree and 5 years of biotechnology operations experience or

• Associates 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)