Aseptic Process Mentor: GMP Compliance & Training Leader

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

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Medical, prescription drug, dental and

Vision coverage

Job summary

Fresenius Kabi USA is seeking an Aseptic Process Mentor for a 12-hour day shift to oversee aseptic operations and mentor operators in aseptic techniques. The role emphasizes GMP compliance, daily audits, and collaboration with Production, Quality, and Training leadership.

Ideal candidates hold a Bachelor’s in Microbiology or Life Sciences (or an Associate’s with pharma manufacturing training) and have 1–3 years of related experience, with English as the operating language.

Qualifications

• Bachelor’s degree in Microbiology or Life Sciences.
• Or an Associate’s Degree plus a certificate in pharmaceutical manufacturing with 1–3 years of related experience.
• Aseptic processing experience and gowning qualifications desirable.
• English as the primary business language; ability to speak/read/write English.

Responsibilities

• Monitor aseptic core and mentor operators on aseptic technique to ensure GMP compliance.
• Report metrics to site management on a regular basis.
• Perform daily visual audits of aseptic behavior during fills and lyophilizer loading.
• Take prompt action for non-compliance or undesired behavior in the complex.
• Collaborate with Production/Quality/Training leadership to Recommend aseptic process improvements.
• Communicate performance feedback to operators and supervisors in aseptic core.

Skills

Aseptic processing

Mentoring

Quality compliance

English proficiency

Education

Bachelor’s Degree in Microbiology or Life Sciences

Associates Degree + certificate in pharmaceutical manufacturing

Job description

Fresenius Kabi USA is seeking an Aseptic Process Mentor for a 12-hour day shift to oversee aseptic operations and mentor operators in aseptic techniques. The role emphasizes GMP compliance, daily audits, and collaboration with Production, Quality, and Training leadership.

Ideal candidates hold a Bachelor’s in Microbiology or Life Sciences (or an Associate’s with pharma manufacturing training) and have 1–3 years of related experience, with English as the operating language.