Location: Onsite Status Type: Full Time QUALIFICATIONS: Required: • 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 Preferred: • 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 Skills & Competencies: • 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 Physical Requirements: • 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. RESPONSIBILITIES: • 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