Aseptic Process Excellence Lead

Fresenius Kabi; Melrose Park (FL); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid time off

Job summary

Fresenius Kabi in Melrose Park, FL is seeking an experienced leader to head the Aseptic Training and Mentorship Program. You will shape aseptic technique, contamination control, and operator performance across regulated manufacturing environments, driving training effectiveness and compliance.

Responsibilities include directing staff, developing curricula, and partnering with Production, Quality, Validation, and Engineering to uphold aseptic excellence and continuous improvement across the site.

Qualifications

• Bachelor's degree in Microbiology, Biology, or a related scientific field.
• Minimum of 3 years of Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications.
• 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 for aseptic training and mentorship across the site.
• Direct planning, staffing, and schedules for Aseptic Mentor resources.
• Lead development, coaching, and performance management of Aseptic Training staff.
• Establish KPIs and priorities to support compliance, quality, and continuous improvement.
• Serve as site SME for aseptic behavior and contamination control with cross-functional guidance.
• Oversee curricula, qualification programs, and competency assessment processes.

Skills

Aseptic training leadership

Regulatory compliance

Data-driven analysis

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Microbiology/related field

Job description

Fresenius Kabi in Melrose Park, FL is seeking an experienced leader to head the Aseptic Training and Mentorship Program. You will shape aseptic technique, contamination control, and operator performance across regulated manufacturing environments, driving training effectiveness and compliance.

Responsibilities include directing staff, developing curricula, and partnering with Production, Quality, Validation, and Engineering to uphold aseptic excellence and continuous improvement across the site.