• Training Coordinator, Drug Product

    Fujifilm (Holly Springs, NC)


    Position Overview

    The Training Coordinator for Drug Product Finished Goods develops, implements, and oversees training programs for personnel involved in drug product manufacturing, filling, inspection, and packaging operations. This role ensures compliance with cGMP regulations, enhances operational efficiency, and

     

    supports continuous improvement initiatives within sterile and non-sterile finished goods production in a 24/7 manufacturing facility

    Job Description

    What You’ll Do

    • Designs and implements training programs for drug product manufacturing, including formulation, aseptic filling, visual inspection, and packaging

    • Develops and maintains training materials such as standard operating procedures (SOPs), work instructions (WIs), and e-learnings

    • Conducts classroom and hands-on training sessions for operators, technicians, and support staff

    • Assesses and qualifies employees through written exams, practical demonstrations, and hands-on evaluations

    • Supports aseptic process simulations and interventions for personnel qualification

    • Conducts retraining and refresher courses as needed to address deviations or regulatory change

    • Monitors production floor activities to ensure adherence to trained procedures and identifies areas for improvement

    • Works with Quality Assurance (QA) and Manufacturing teams to enhance training effectiveness, identify compliance gaps, and address changes asneeded

    • Supports regulatory and internal audits by maintaining and providing training records, tracking personnel qualification status, addressingcompliance questions, and participating in audit responses

    • Stays updated on industry best practices, new technologies, and regulatory updates related to drug product manufacturing

    • Adapts to changing regulatory requirements and implements new training approaches accordingly

    • Serves as a subject matter expert (SME) for training in sterile and non-sterile drug product manufacturing

    • Coaches and mentors new hires and existing employees to ensure a culture of compliance, operational excellence, and continuous learning

    • Provides guidance on aseptic techniques, gowning, material handling, and contamination control

    • Ensures training aligns with regulatory requirements from the Food & Drug Administration (FDA), European Medicines Agency (EMA), Medicines &Healthcare products Regulatory Agency (MHRA), and other health authorities

    • Stays updated on training best practices, instructional design, and adult learning principles

    • Uses aseptic process simulations and sterility assurance strategies to ensure regulatory compliance

    • Works independently while also collaborating cross-functionally to drive a culture of compliance

    • Other assignment, as needed

    Basic Requirements

    • High School Diploma/GED and 4 years direct experience **OR**

    • Associate degree in life sciences with 2 years of direct experience **OR**

    • Bachelors in life sciences or education with no experience **OR**

    • Equivalent military training/experience

    • 2-5 years in training coordination or instructional design

    Preferred Requirements

    • Experience developing and delivering technical training programs

    • Experience with learning management systems

    • Bioworks Certificate

    WORKING CONDITIONS & PHYSICAL REQUIREMENTS

    + Ability to sit for prolonged periods of time

    + Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers

     

    _To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._

     

    **Job Locations** _US-NC-Holly Springs_

    **Posted Date** _2 days ago_ _(10/30/2025 9:13 AM)_

    **_Requisition ID_** _2025-36001_

    **_Category_** _Manufacturing_

    **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_