Aseptic Process Excellence Lead

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a leader to manage the Aseptic Training and Mentorship Program across a multi-shift site, directing planning, staffing, and curriculum development for aseptic operations.

You will ensure training effectiveness, regulatory compliance, and contamination control, partnering with Production, Quality, Validation, Engineering, and Maintenance to drive continuous improvement.

Qualifications

• Bachelor's degree in Microbiology 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.
• Experience with FDA inspections and responses.
• Ability to work weekends as needed.

Responsibilities

• Provide strategic leadership and oversight for the Aseptic Training and Mentorship Program, ensuring continued development, effectiveness, and compliance across the site.
• Direct the planning, allocation, and management of Aseptic Mentor resources, staffing models, and schedules for continuous operational support and training coverage.
• Lead development, coaching, performance management, and succession planning of Aseptic Training personnel.
• Establish departmental goals and KPIs that support regulatory compliance and continuous improvement.
• Serve as SME for aseptic behavior and contamination control, guiding cross-functional teams including Production, Quality, Validation, Engineering, and Maintenance.
• Oversee training program design, implementation, and qualification activities across facilities.
• Provide leadership during regulatory inspections and customer audits related to aseptic training and qualifications.

Education

Bachelor's degree in Microbiology or related field

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a leader to manage the Aseptic Training and Mentorship Program across a multi-shift site, directing planning, staffing, and curriculum development for aseptic operations.

You will ensure training effectiveness, regulatory compliance, and contamination control, partnering with Production, Quality, Validation, Engineering, and Maintenance to drive continuous improvement.