Aseptic Process Mentor

Fresenius Kabi USA • Melrose Park, IL

2d • Onsite

About The Position

This role involves monitoring the aseptic core to ensure continuous compliance with Good Manufacturing Practices (GMPs) and providing mentorship on aseptic techniques to operators. The position requires regular reporting of metrics to site management and conducting daily visual audits of aseptic behavior within the core during fills and lyophilizer loading. Immediate action is expected for any observed non-compliance or undesired behavior. The Aseptic Process Mentor will partner with Production, Quality, and Training leadership to recommend enhancements to the aseptic process, communicate feedback to operators and supervisors, and provide corrective action training based on visual audits. Responsibilities also include daily inspections of the aseptic core's physical conditions, reviewing aseptic technique for media fills, assisting with documentation and vial count verification, escorting non-gown qualified individuals, and training personnel in aseptic techniques and processes. Additional duties may be assigned.

Requirements

• Bachelor’s Degree in Microbiology or Life Sciences OR a combination of Associates Degree and/or Certificate with a focus on pharmaceutical manufacturing PLUS one to three years of related experience.
• The ability to gown and work in an aseptic manufacturing environment.
• Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Nice To Haves

• Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.

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.
• Provide escort of non-gown qualified individuals on an as needed basis.
• Train personnel in Aseptic Techniques and processes.
• Assumes additional duties and responsibilities as assigned.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level