Aseptic Process Mentor (12-Hour Overnight Shift)

Fresenius SE & Co. KGaA; Melrose Park, Northern (IL, KY); Hybrid; USD 34,000 - 41,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid time off

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a quality-focused professional to monitor aseptic core operations and mentor operators in aseptic technique within GMP-compliant processes.

The role emphasizes daily visual audits, immediate corrective actions, documentation review, and collaboration with Production/Quality/Training leadership to enhance aseptic practices. Strong English communication and hands-on gowning are required.

Qualifications

• Bachelor’s degree in Microbiology or Life Sciences.
• Or a combination of Associates Degree and/or Certificate with focus on pharmaceutical manufacturing plus one to three years of related experience.
• Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
• The 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.
• Assumes additional duties and responsibilities as assigned.

Skills

Aseptic technique mentoring

GMP compliance

Quality improvement collaboration

Education

Bachelor’s Degree in Microbiology or Life Sciences

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

Job description

Job Summary

Starting Hourly Rate: $25 per hour.
Overnight Shift Differential: $1.75 per hour.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Monitors aseptic core to ensure continual compliance with GMP's and provides mentoring on aseptic technique with operators. Reports metrics to site management on a regular basis.

Job 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.

• Assumes additional duties and responsibilities as assigned.

Job 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.

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

• The ability to gown and work in an aseptic manufacturing environment.

The Company’s primary business language is English. The successful candidate 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand Fresenius Kabi have the right to end the employment relationship at any time,in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.