Senior Aseptic Training Lead

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Bonus plan

401(k) plan with company contributions

Health benefits

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a skilled professional to lead aseptic training programs, driving regulatory compliance and site quality objectives. The role focuses on developing and delivering training for aseptic technique, gowning, and contamination control across the manufacturing organization.

Responsibilities include coaching, curriculum development, cross-functional collaboration with QA, Manufacturing and Technical Operations, and ongoing performance improvement

Qualifications

• Bachelor's degree in microbiology, biology, or related scientific field.
• Minimum 5 years of aseptic processing experience, including proficiency in aseptic gowning qualifications.
• Ability to gown and work in an aseptic manufacturing environment.
• Industrial certification and/or formal Training in Aseptic Operations.
• Thorough knowledge of cGMPs in a pharmaceutical environment.
• Demonstrated leadership ability to teach, mentor, and communicate effectively.
• Available to work evenings and weekends as needed.

Responsibilities

• Coordinates and delivers hands-on, classroom, and virtual reality training programs for new and existing employees requiring aseptic processing and gowning qualifications.
• Serves as a trusted coach and mentor to manufacturing personnel, reinforcing aseptic behaviors, cleanroom practices, and contamination control principles through ongoing observation, feedback, and education.
• Providers qualification training and developmental coaching for Aseptic Process Mentors, promoting consistency in training delivery and aseptic best practices across the organization.
• Develops, updates, and continuously improves aseptic training curricula, modules, and qualification programs to support regulatory compliance, operational effectiveness, and workforce capability.
• Collaborates with Manufacturing Quality, and Technical Operations teams to identify opportunities for continuous improvement in aseptic processing, contamination control, and operator performance.
• Facilitates the standardization of aseptic techniques, cleanroom behaviors, and contamination control practices through training, coaching, and knowledge-sharing initiatives.
• Partners with cross-functional teams to support airflow visualization studies, process evaluations, and contamination control assessments as needed.
• Provides targeted retraining and corrective action coaching based on environmental monitoring excursions, audit observations, investigation findings, and operational trends.
• Authors and supports investigations related to personnel aseptic practices, operator behaviors, and contamination control events, providing recommendations for training and performance improvement.
• Develops, revises, and maintains procedures, training materials, and guidance documents associated with aseptic technique, gowning qualification, and contamination control.
• Monitors and analyzes training effectiveness, qualification data, and performance trends to identify improvement opportunities and support site quality objectives.
• Serves as a subject matter expert and resource for operators, supervisors, and functional teams, providing guidance and coaching on aseptic practices, contamination control expectations, and cleanroom behaviors.
• Conducts process simulation (media fill) training, monitors participation and qualification status, and provides coaching to strengthen aseptic technique and operator readiness.
• Provides real-time mentoring and constructive feedback to operators and supervisors within aseptic processing areas to reinforce compliant behaviors and drive sustainable performance improvements.
• Supports Aseptic Process Mentors with operator assessments, qualification activities, and coaching initiatives designed to enhance employee knowledge, confidence, and performance.
• Escorts non-gown-qualified personnel into controlled manufacturing environments when required, ensuring adherence to contamination control practices and cleanroom requirements.
• All employees are responsible for ensuring compliance to company documents, programs and activities related to health, safety, environment, energy, and quality management systems, as per job roles and responsibilities.

Skills

Aseptic processing

Aseptic gowning

Leadership / mentorship

Regulatory compliance (cGMPs)

Education

Bachelor's degree in microbiology, biology, or related scientific field

Industrial certification and/or formal Training in Aseptic Operations

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a skilled professional to lead aseptic training programs, driving regulatory compliance and site quality objectives. The role focuses on developing and delivering training for aseptic technique, gowning, and contamination control across the manufacturing organization.

Responsibilities include coaching, curriculum development, cross-functional collaboration with QA, Manufacturing and Technical Operations, and ongoing performance improvement