Manager, Training & Development

Enable Injections Inc.•Sharonville, OH

40d•Onsite

About The Position

The Manager, Training & Development delivers and oversees learning and development for production personnel in a regulated manufacturing environment. The role provides hands-on and classroom instruction, qualifies operators through documented training and competency assessments, and develops and maintains curricula, job aids, visual aids, and training records aligned with controlled documents and quality requirements. The position manages training administration, curricula, certifications, training records, reporting, budgets, and resources. It works with Production, Quality, Engineering, Human Resources, and Quality Systems to coordinate training and maintain operator qualifications. The role also evaluates training effectiveness and operator proficiency, addresses training-related gaps, supports corrective and preventive actions, and drives improvements to onboarding, process consistency, and employee development.

Requirements

Bachelor’s degree in Human Resources, Learning and Development, Business Administration, Education, or a relevant field.
At least 6 years of experience training or mentoring production personnel in a regulated environment.
Experience designing, implementing, delivering, and managing learning and development initiatives.
Experience working with controlled work instructions, SOPs, and training documentation.
Complete Enable Injections’ internal trainer qualification/certification process within 90 days of hire, in accordance with Quality Systems requirements.
Knowledge and experience building effective, engaging learning modules.
Experience managing learning technologies, certification programs, skills assessments, and reporting metrics.
Strong platform and one-on-one instructional skills, including the ability to explain technical steps clearly to varied audiences.
Ability to develop, design, and deliver 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 and collaboratively with team members as needed.
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.
Intermediate computer skills, including Outlook, Word, Excel, and 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.
Willingness and ability to work overtime and across shifts as needed to deliver training on weekdays and weekends.
Ability to gown and work within a clean room and/or lab environment.
Ability to stand and walk the production floor for extended periods and lift and lower boxes or handle equipment weighing up to 25 lbs.

Nice To Haves

Master’s degree in Human Resources, Learning and Development, Business Administration, Education, or a relevant field.
Three years of 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.

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 requirements.
Verify training effectiveness using established methods, such as written assessments, hands-on demonstrations, or supervisor-verified competency checks, before qualifying operators.
Track training due dates, certifications, requalification intervals, and completion metrics, escalating overdue items as appropriate.
Support root cause analysis and corrective/preventive actions (CAPA) when training or human error is identified as a contributing factor.
Revise and re-deliver training following document changes, engineering changes, or process improvements.
Evaluate operator proficiency on the production floor and coach operators to close identified skill gaps.
Maintain the training matrix so 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 improvements to training effectiveness, onboarding speed, and process consistency, supporting 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 implement learning and development programs.
Manage training budgets and resources.