Aseptic Process Mentor: GMP Training Lead

RXinsider LTD.; Melrose Park, Northern (IL, KY); Hybrid; USD 28,000 - 40,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Holidays & personal days

Employee assistance program

Medical, dental, and vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks an aseptic manufacturing professional to monitor core operations and mentor operators in aseptic techniques. You will ensure compliance with GMP and support continuous improvement within the aseptic filling and lyophilizer processes.

The role requires a degree in microbiology or life sciences or a related certificate with 1–3 years of relevant experience, plus gowning qualifications and the ability to work in a cleanroom.

Qualifications

• Bachelor’s Degree in Microbiology or Life Sciences.
• Associates Degree/Certificate with focus on pharmaceutical manufacturing plus 1–3 years of related experience.
• Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
• Ability to gown and work in an aseptic manufacturing environment.

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 by personnel in the complex 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.

Skills

Aseptic Processing

Aseptic Gowning

GMP compliance

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree/Certificate in pharmaceutical manufacturing + 1–3 years experience

Job description

Fresenius Kabi in Melrose Park, IL seeks an aseptic manufacturing professional to monitor core operations and mentor operators in aseptic techniques. You will ensure compliance with GMP and support continuous improvement within the aseptic filling and lyophilizer processes.

The role requires a degree in microbiology or life sciences or a related certificate with 1–3 years of relevant experience, plus gowning qualifications and the ability to work in a cleanroom.