Manager, Training & Development

Cintrifuse; Cincinnati (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

CintraFuse is seeking an experienced Learning & Development trainer to deliver hands-on and classroom training for production personnel, aligned to controlled documents and SOPs. You will qualify operators through on-the-job training, develop curricula, and maintain audit-ready records per GDP standards.

Ideal candidates have 6+ years of regulated environment training, strong instructional skills, and familiarity with GMP/GDP, LMS tools, and cross-functional collaboration.

Qualifications

• Bachelor’s degree in HR, L&D, Business Admin, 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.
• Complete Enable Injections’ internal trainer qualification/certification within 90 days of hire, per Quality Systems.

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 audit-ready individual training records per GDP and quality system requirements.
• Verify training effectiveness via assessments, demonstrations, or supervisor-verified competency checks.
• Own training due dates, certifications, requalification intervals, and completion metrics; escalate overdue items as needed.
• Support CAPA where training or human error is a contributing factor.
• Revise and re-deliver training after document/engineering changes.
• Evaluate operator proficiency and provide coaching to close skill gaps.
• Maintain training matrix to reflect qualified operators by line, process, and shift.
• Generate reports on training completion, qualification status, and effectiveness.
• Collaborate with Production, Quality, Engineering, and HR to schedule training around demand and onboarding.
• Coordinate with Quality Systems on new-hire qualification timing for GDP training.
• Communicate training gaps and process deviations to appropriate personnel.
• Drive improvements to training effectiveness and onboarding speed.
• Manage day-to-day training administration within SuccessFactors curriculum structure and documentation links.
• Propose curriculum or system configuration changes with Quality Systems.
• Oversee learning materials and resources for effective implementation of programs.
• Manage training budgets and resources.

Skills

Instructional skills

Curriculum design

GDP/GMP awareness

Documentation discipline

Independent work

Communication skills

Facilitation

Cross-functional collaboration

Education

Bachelor’s degree

Master’s degree

Trainer certifications (CPTD/CPTM)

Tools

SuccessFactors

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
• 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

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