Aseptic Process Mentor: Lead Operator Training & Compliance

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 29,000 - 40,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision

Wellness program

Life insurance

Disability

Job summary

Fresenius Kabi USA, LLC is seeking a qualified individual to monitor aseptic core operations and mentor operators in aseptic techniques within a GMP environment. The role emphasizes ensuring compliant filling processes and accurate documentation.

The candidate should have a Bachelor’s degree in Microbiology or Life Sciences and related experience in pharmaceutical manufacturing, with aseptic gowning qualifications preferred. A robust benefits package accompanies this position.

Qualifications

• Bachelor's Degree in Microbiology or Life Sciences or related field.
• 1-3 years of related experience in pharmaceutical manufacturing.
• Aseptic processing experience desirable.
• Ability to gown and work in 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 observed.
• Partner with Production/Quality/Training Leadership to recommend aseptic process enhancements.
• Communicate openly to operators and supervisors in aseptic core for mentoring.
• Provide corrective action training based on visual audits and feedback.

Skills

Aseptic technique

Quality monitoring

Training others

Education

Bachelor's Degree in Microbiology or Life Sciences

Tools

Aseptic gowning

Job description

Fresenius Kabi USA, LLC is seeking a qualified individual to monitor aseptic core operations and mentor operators in aseptic techniques within a GMP environment. The role emphasizes ensuring compliant filling processes and accurate documentation.

The candidate should have a Bachelor’s degree in Microbiology or Life Sciences and related experience in pharmaceutical manufacturing, with aseptic gowning qualifications preferred. A robust benefits package accompanies this position.