Aseptic Process Mentor – Overnight GMP Guidance

Fresenius; Melrose Park (IL); Hybrid; USD 28,000 - 40,000; Full time

Benefits offered by this job

401(k) with company contributions

Health benefits (medical, dental, and视

Paid vacation and holidays

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a qualified candidate to monitor aseptic core operations and mentor operators to ensure GMP compliance. The role includes audits, training, and collaboration with Production, Quality, and Training leadership.

The successful candidate will have a degree in microbiology or life sciences, aseptic processing experience, and the ability to gown in a controlled manufacturing environment. English communication is essential.

Qualifications

• Bachelor’s degree in Microbiology or Life Sciences required.
• Associates degree and/or certificate with focus on pharmaceutical manufacturing plus 1–3 years related experience.
• Aseptic processing experience and gowning qualifications desirable.
• Ability to gown and work in an aseptic manufacturing environment.

Responsibilities

• Monitor Filling Operators by daily visual audits of aseptic behavior inside the core during fills and lyophilizer loading.
• Take immediate action when non‑compliance is observed.
• Partner with Production/Quality/Training Leadership to recommend aseptic process enhancements.
• Communicate openly to operators and supervisors to mentor on observed performance.
• Provide corrective action training based on visual audits and immediate feedback.
• Complete daily inspections of the aseptic core’s physical conditions.
• Review aseptic technique with media fills and assist with documentation and final vial count verification.

Skills

Aseptic processing experience

Aseptic gowning qualifications

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree or Certificate in pharmaceutical manufacturing

Job description

Fresenius Kabi in Melrose Park, IL is seeking a qualified candidate to monitor aseptic core operations and mentor operators to ensure GMP compliance. The role includes audits, training, and collaboration with Production, Quality, and Training leadership.

The successful candidate will have a degree in microbiology or life sciences, aseptic processing experience, and the ability to gown in a controlled manufacturing environment. English communication is essential.