Aseptic Process Excellence Leader

Fresenius SE & Co. KGaA; Melrose Park, Northern (IL, KY); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health, dental, and vision benefits

Job summary

Fresenius Kabi USA is seeking a senior leader to head the Aseptic Training and Mentorship Program at our Melrose Park, IL site. You will provide strategic direction for aseptic technique, contamination control, and operator performance within regulated manufacturing environments.

You will direct training systems, assess gaps, and drive continuous improvement across four shifts, partnering with Production, Quality, Validation, Engineering, and Maintenance to achieve operational excellence and

Qualifications

• Bachelor's degree required in Microbiology, Biology, or related field.
• Minimum of 3 years of Aseptic Processing experience.
• Industrial Certification and/or formal Training in Aseptic Operations a plus.
• Thorough knowledge of cGMPs in a pharmaceutical environment.
• Proven experience in FDA inspections and responses.
• Ability to work weekends as needed.

Responsibilities

• Provide strategic leadership and oversight for the Aseptic Training and Mentorship Program across the site.
• Direct planning, allocation, and management of Aseptic Mentor resources and schedules.
• Lead development, coaching, and performance management of Aseptic Training personnel.
• Establish KPIs and strategic priorities for operational excellence and compliance.
• Serve as SME for aseptic behavior and contamination control practices across teams.
• Partner with site leadership to assess training effectiveness and trends.
• Provide regular updates to Production and Quality Management on aseptic compliance.
• Oversee design, implementation, and continuous improvement of aseptic curricula and qualification programs.
• Ensure onboarding and ongoing development of Aseptic Filling Operators and gown-qualified personnel.
• Lead cross-site standardization of aseptic practices and cleanroom management.
• Oversee training simulations (media fill) and qualification activities.
• Collaborate with Operations, QA, Validation, and Maintenance on performance expectations.
• Lead investigations and CAPAs related to environmental monitoring excursions and aseptic events.
• Support regulatory inspections and customer audits as primary aseptic training lead.

Skills

Leadership

Aseptic Training

Regulatory Compliance

Training & Mentorship

Cross-functional Collaboration

Education

Bachelor's degree in Microbiology / Biology or related field

Tools

GMP knowledge

Job description

Fresenius Kabi USA is seeking a senior leader to head the Aseptic Training and Mentorship Program at our Melrose Park, IL site. You will provide strategic direction for aseptic technique, contamination control, and operator performance within regulated manufacturing environments.

You will direct training systems, assess gaps, and drive continuous improvement across four shifts, partnering with Production, Quality, Validation, Engineering, and Maintenance to achieve operational excellence and