Manager, Training & Development

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Parkview Medical Center, Inc. is seeking an experienced Learning & Development Trainer to lead hands-on and classroom training for production personnel in a regulated environment. You will design curricula, maintain compliant training records, and ensure training effectiveness across multiple shifts.

The role requires at least 6 years of experience, knowledge of GDP/GMP, and ability to collaborate with Quality, Engineering, and HR to drive continuous improvement in learning initiatives.

Qualifications

• Bachelor's degree in HR, 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 trainer qualification/certification process within 90 days of hire per Quality Systems requirements.
• Knowledge and experience building effective and engaging learning modules.
• Experience managing learning technologies, certification programs, skills assessments, 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 documented competency assessments.
• Develop and maintain training curricula, job aids, and visual aids aligned to current controlled documents.
• Maintain audit-ready individual training records per GDP requirements.
• Verify training effectiveness using established methods prior to qualifying an operator.
• Own tracking for training due dates, certifications, requalification intervals, and completion metrics.
• Support CAPA where training or human error is a contributing factor.
• Revise and re-deliver training following document or process changes.
• Evaluate operator proficiency and provide coaching to close skill gaps.
• Maintain training matrix to reflect qualified operators by line, process, and shift.
• Generate and maintain reports on training completion and effectiveness.
• Collaborate with Production, Quality, Engineering, and HR to schedule training around production demand.
• Coordinate with Quality Systems on new-hire qualification timing to align with GDP training.
• Communicate training gaps and process deviations to appropriate personnel.
• Drive improvement initiatives to enhance training effectiveness and onboarding speed.
• Manage day-to-day training administration within the SuccessFactors curriculum structure.
• Propose curriculum design or system configuration changes in partnership with Quality Systems.
• Oversee learning materials and resources needed to implement learning programs.

Skills

Training program development

Learning delivery

LMS management

Documentation & compliance

Communication skills

Cross-functional collaboration

Mentoring/training

Education

Bachelor's degree in HR/LD/Business/Ed

Master's degree preferred

Tools

SuccessFactors LMS

Excel

PowerPoint

Job description

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• 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

Preferred:

• 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
• 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