Aseptic Process Mentor - Lead GMP Compliance (Overnight)

Fresenius Kabi; Melrose Park (IL); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, dental and vision coverage

Life insurance

Wellness program

Paid vacation/holidays

Job summary

Fresenius Kabi in Melrose Park, IL seeks a skilled individual to monitor aseptic core operations and mentor operators to ensure GMP compliance during fills and lyophilizer loading.

The role requires aseptic processing experience and gowning qualifications, with strong English communication. The position emphasizes daily inspections, corrective actions, and collaborative process improvements in a regulated environment.

Qualifications

• Bachelor’s Degree in Microbiology or Life Sciences or equivalent with 1–3 years in pharma manufacturing.
• Aseptic Processing experience and gowning qualifications are desirable.
• Ability to gown and work in an aseptic manufacturing environment with English proficiency.

Responsibilities

• Monitor aseptic core to ensure GMP compliance and mentor operators.
• Conduct daily visual audits of aseptic behavior during fills and lyophilizer loading.
• Take immediate corrective action for non-compliance or undesired behavior.
• Collaborate with Production/Quality/Training leaders to improve aseptic processes.
• Provide corrective-action training based on visual audits and feedback.
• Inspect aseptic core conditions daily and assist with documentation and vial counts.

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree or Certificate in pharmaceutical manufacturing

Aseptic processing experience

Aseptic gowning qualifications

English communication (written/spoken)

Job description

Fresenius Kabi in Melrose Park, IL seeks a skilled individual to monitor aseptic core operations and mentor operators to ensure GMP compliance during fills and lyophilizer loading.

The role requires aseptic processing experience and gowning qualifications, with strong English communication. The position emphasizes daily inspections, corrective actions, and collaborative process improvements in a regulated environment.