- Bachelor’s Degree in Human Resources, Learning and Development, Business Administration, Education, or relevant field.
- Minimum 6 years of experience training or mentoring production personnel in a regulated environment
- Experience designing, implementing, delivering 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
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Preferred:
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- Master’s degree in Human Resources, Learning and Development, Business Administration, Education, or relevant field.
- 3 years prior experience in a manufacturing environment, within 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
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Skills & Competencies:
- Strong platform and one-on-one instructional skills, with the ability to explain technical steps clearly to varied audiences
- Ability to develop, design and delivery training materials, workshops, job aids, certification programs, 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
- 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, certifications, 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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