Job Description

• High school diploma or equivalent required; Associate degree in a technical or life-science discipline preferred
• Minimum 2 years of experience in manufacturing operations, with demonstrated experience training or mentoring production personnel in a regulated environment
• Experience designing, implementing and managing L&D initiatives
• Experience working to controlled work instructions, SOPs, and training documentation
• Completion of Enable Injections' internal trainer qualification/certification process within 90 days of hire, in accordance with Quality Systems requirements
• Knowledge and experience building effective and engaging learning modules
• Experience managing learning technologies, certification programs, skills assessments, and reporting metrics

• 5 years prior experience in the Medical Device or Pharmaceutical industry
• Formal train-the-trainer certification, or experience with a learning management system (LMS) and electronic training records
• Certified Professional in Talent Development (CPTD), Certified Professional in Training Management (CPTM), or similar certification
• Knowledge of adult learning principles and employee development practices

• Strong platform and one-on-one instructional skills, with the ability to explain technical steps clearly to varied audiences
• Ability to develop training materials, workshops, job aids, and competency assessments from controlled work instructions
• Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Strong attention to detail and documentation discipline in maintaining training records
• Ability to work independently in a dynamic, quality-driven environment
• Excellent verbal and written communication skills
• Strong facilitation, presentation, and interpersonal abilities
• Ability to collaborate with and provide constructive feedback to operators, supervisors, and other departments
• Must be able to work independently as well as collaboratively with team members as needed
• Intermediate computer skills (Outlook, Word, Excel, PowerPoint); working knowledge of an LMS or electronic training system
• Ability to update and/or create training material
• Working knowledge of Learning Management Systems, including curriculum assignment and training record entry, as configured and maintained by Quality Systems

• Willingness and ability to work overtime and across shifts as needed to deliver training on both weekdays and weekends
• Must be able to gown and work within a clean room and/or lab environment
• Ability to stand and walk the production floor for extended periods, and to lift and lower boxes or handle equipment weighing up to 25 lbs.

• Deliver hands-on and classroom training to production personnel on approved work instructions, SOPs, and manufacturing processes
• Qualify new and transferring operators through structured on-the-job training and documented competency assessments
• Develop and maintain training curricula, job aids, and visual aids aligned to current controlled documents
• Maintain accurate, audit-ready individual training records in accordance with quality system and Good Documentation Practices (GDP) requirements
• Verify training effectiveness using established methods(e.g., written assessment, hands-on demonstration, or supervisor-verified competency check) prior to qualifying an operator
• Own the tracking for training due dates, requalification intervals, and completion metrics, escalating overdue items as appropriate
• Support root cause analysis and corrective/preventive actions (CAPA) where training or human error is identified as a contributing factor
• Revise and re-deliver training promptly following document changes, engineering changes, or process improvements
• Evaluate operator proficiency on the floor and provide coaching to close identified skill gaps
• Maintain the training matrix so that staffing plans reflect qualified operators by line, process, and shift
• Generate and maintain reports on training completion, qualification status, and effectiveness
• Collaborate with Production, Quality, Engineering, and Human Resources to schedule training around production demand and onboarding
• Coordinate with Quality Systems on new-hire operator qualification timing to align with New Employee Orientation and GDP training requirements
• Communicate training gaps, recurring performance issues, and process deviations to appropriate personnel
• Drive improvement initiatives to enhance training effectiveness, onboarding speed, and process consistency, ensuring continuous employee learning and development
• Manage day-to-day training administration within the curriculum structure, document linkage, and system configuration established and maintained in SuccessFactors
• Propose and justify curriculum design or system configuration changes in partnership with Quality Systems
• Oversee learning materials and resources needed to effectively implement learning and development programs
• Manage training budgets and resources

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