Aseptic Process Mentor | GMP Training & Compliance

Fresenius Kabi; Melrose Park (IL); On-site; USD 71,635,000 - 86,789,000; Full time

Job summary

Fresenius Kabi in Melrose Park, IL, is seeking an aseptic production professional to monitor the aseptic core during fills and lyophilizer loading. The role emphasizes mentoring operators, ensuring GMP compliance, and daily visual audits of aseptic behavior.

Candidates should have a bachelor’s degree in microbiology or life sciences or related certification with 1–3 years of aseptic manufacturing experience; strong English communication and willingness to train others are required.

Qualifications

• Bachelor’s degree or equivalent experience in microbiology or life sciences.
• Experience with aseptic processing and gowning in controlled environments.
• Strong documentation and adherence to GMP/compliance requirements.

Responsibilities

• Monitor Filling Operators by completing daily visual audits of aseptic behavior inside the core during fills and lyophilizer loading.
• Take immediate action when non-compliance and/or undesired behavior is observed.
• Partner with Production/Quality/Training Leadership to make recommendations for enhancements to aseptic process.
• Communicate openly to operators and supervisors in aseptic core to provide mentoring regarding observed performance.
• Provide corrective action training based on visual audit by immediate feedback.
• Complete daily inspections of the physical conditions of the aseptic core.
• Review aseptic technique associated with media fills and help complete documentation and final vial count verification.
• Presence in the Aseptic complex on a regular basis is essential.
• Provide escort of non-gown qualified individuals on an as needed basis.
• Expected to train personnel in Aseptic Techniques and processes.
• Assumes additional duties and responsibilities as assigned.

Skills

Aseptic technique

Mentoring

English communication

Documentation

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree or Certificate in pharmaceutical manufacturing

Tools

Aseptic gowning qualifications

Gowning in aseptic environment

Job description

Fresenius Kabi in Melrose Park, IL, is seeking an aseptic production professional to monitor the aseptic core during fills and lyophilizer loading. The role emphasizes mentoring operators, ensuring GMP compliance, and daily visual audits of aseptic behavior.

Candidates should have a bachelor’s degree in microbiology or life sciences or related certification with 1–3 years of aseptic manufacturing experience; strong English communication and willingness to train others are required.