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.
Familiarity with controlled work instructions, SOPs, and training documentation.
Completion of Enable Injections' internal trainer qualification/certification process within 90 days of hire.
Knowledge of building effective and engaging learning modules.
Experience managing learning technologies and reporting metrics.
Responsibilities
Deliver hands-on and classroom training to production personnel on approved work instructions and SOPs.
Qualify new and transferring operators through structured on-the-job training and competency assessments.
Develop and maintain training curricula and job aids aligned to current controlled documents.
Maintain accurate, audit-ready individual training records in accordance with quality system requirements.
Verify training effectiveness using established assessment methods before qualifying an operator.
Own tracking for training due dates and escalate overdue items as appropriate.
Support root cause analysis and corrective actions where training or human error is identified.
Benefits
Opportunity for professional development and continuous learning.
Engagement in a dynamic, quality-driven environment.
Collaboration with cross-functional teams including Production, Quality, and Engineering.
Access to advanced learning technologies and resources.
Potential for career advancement within the organization.
Full Job Description
Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
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
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
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
