Production Trainer

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• 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 daysof 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 inmaintainingtraining 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 andmaintainedby Quality Systems

• Willingness and ability to work overtime and across shifts as needed to deliver training on both weekdays and weekends
• Must be able togownand work within a clean room and/or lab environment
• Ability to stand andwalkthe 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 andmaintaintraining curricula, job aids, and visual aids aligned to current controlled documents
• Maintain accurate, audit-ready individual training recordsin accordance with quality system and Good Documentation Practices (GDP) requirements
• Verify training effectiveness usingestablishedmethods(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 itemsas 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 operatorproficiencyon 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 andmaintainreports 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 andGDPtraining requirements
• Communicate training gaps, recurring performance issues, and process deviations to appropriate personnel
• Drive improvement initiatives to enhance training effectiveness, onboarding speed, and process…