About this role
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