Training Coordinator, Drug Product

Training Coordinator For Drug Product Finished Goods

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 as needed

Supports regulatory and internal audits by maintaining and providing training records, tracking personnel qualification status, addressing compliance 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