Aseptic Process Mentor (12-Hour Overnight Shift)

Ivenix, Inc.; Melrose Park, Northern (IL, KY); Hybrid; USD 28,000 - 40,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation and holidays

Health benefits: medical, dental, and/

Job summary

Fresenius Kabi is seeking a qualified candidate for an aseptic manufacturing role in Illinois. The position focuses on monitoring the aseptic core, mentoring operators in aseptic techniques, and ensuring GMP compliance during fills and lyophilizer loading.

Strong English communication is essential in this regulated environment. Responsibilities include daily audits, action on non-compliance, collaboration with Production/Quality/Training leadership, and ongoing training of personnel in aseptic

Qualifications

• Bachelor's Degree in Microbiology or Life Sciences required; or Associates Degree/certificate with pharma manufacturing focus plus 1–3 years of related experience.
• Aseptic Processing experience and gowning qualifications desirable.
• Company language is English; ability to speak/read/write in English is essential in a regulated environment.

Responsibilities

• Monitor aseptic core to ensure GMP compliance and mentor operators in aseptic technique.
• Report metrics to site management on a regular basis.
• Perform daily visual audits of aseptic behavior during fills and lyophilizer loading, taking immediate action for non-compliance.

Skills

Aseptic technique

Mentoring

Documentation

Education

Bachelor's Degree in Microbiology or Life Sciences

Associates Degree with pharma focus + 1–3 years experience

Tools

Aseptic gowning Qualifications

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 and vision 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 permanent employment arrangement. All employment is at‑will, meaning both the employee and 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 applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr