Aseptic Trainer

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

Benefits offered by this job

401(k) plan with company contributions

Health benefits: medical, prescription

Dental and vision coverage

Paid vacation, holidays and personal/"

Employee assistance program

Life insurance & disability

Wellness program

Job summary

Fresenius Kabi in the United States is seeking an experienced Aseptic Training Lead to design, implement, and oversee aseptic training programs that ensure compliance with regulatory requirements and site quality objectives.

You will lead initiatives to qualify and develop personnel in aseptic technique, gowning, and contamination control, partnering with Quality, Manufacturing, Operations, Validation, and Technical Services to close performance gaps and elevate operator proficiency.

Qualifications

• Bachelor's degree in microbiology, biology, or related 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

• Coordinate and deliver hands-on, classroom, and virtual reality training programs for new and existing employees requiring aseptic processing and gowning qualifications.
• Serve as a trusted coach and mentor to manufacturing personnel, reinforcing aseptic behaviors, cleanroom practices, and contamination control principles through ongoing observation, feedback, and education.
• Provide qualification training and developmental coaching for Aseptic Process Mentors, promoting consistency in training delivery and aseptic best practices across the organization.
• Develop, update, and continuously improve aseptic training curricula, modules, and qualification programs to support regulatory compliance, operational effectiveness, and workforce capability.
• Collaborate with Manufacturing Quality, and Technical Operations teams to identify opportunities for continuous improvement in aseptic processing, contamination control, and operator performance.
• Facilitate the standardization of aseptic techniques, cleanroom behaviors, and contamination control practices through training, coaching, and knowledge-sharing initiatives.
• Partner with cross-functional teams to support airflow visualization studies, process evaluations, and contamination control assessments as needed.
• Provide 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.

Education

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

Job description

Job Summary

Salary Range: $80,000 to $100,000
This position is eligible to participate in a bonus plan with a target of 6% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Responsible for the strategic development, implementation, and oversight of aseptic training programs designed to ensure compliance with regulatory requirements, industry standards, and site quality objectives. Leads initiatives to qualify, develop, and sustain the capabilities of new and existing personnel in aseptic technique, aseptic gowning, and contamination control practices. Partners cross-functionally with Quality, Manufacturing, Operations, Validation, and Technical Services to identify performance gaps, drive training effectiveness, and enhance operator proficiency. Provides leadership in continuous improvement efforts focused on aseptic processing excellence, human performance, contamination prevention, and risk reduction, ensuring a culture of compliance, operational excellence, and continuous learning throughout the organization.

Job 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.

Job Requirements

• 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.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.