Aseptic Process Mentor (12-Hour Day Shift)

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

Benefits offered by this job

401(k) plan

Paid vacation

Personal days

Employee assistance program

Health benefits

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks a qualified candidate for a role in aseptic processing. The position emphasizes maintaining GMP standards within the aseptic core, mentoring operators, and ensuring compliant production practices.

The ideal candidate will have a Bachelor's or equivalent in life sciences, aseptic experience, and strong English communication skills to perform in a heavily regulated setting.

Qualifications

• Bachelor's Degree in Microbiology or Life Sciences required.
• 1–3 years of related experience with a combination of associate degree/certificate acceptable.
• Aseptic Processing experience is desirable.
• English language proficiency required to read, write, and understand procedures in a regulated environment.

Responsibilities

• Monitors aseptic core to ensure GMP compliance and mentors operators.
• Conducts daily visual audits of aseptic behavior during fills and lyophilizer loading.
• Take action for non-compliance and observed undesired behavior.
• Collaborates with Production/Quality/Training leadership to improve aseptic processes.
• Communicates with operators and supervisors to provide mentoring on performance.
• Provides corrective-action training based on visual audits and feedback.
• Completes daily inspections of the aseptic core facility conditions.
• Reviews aseptic technique related to media fills and documentation.
• Visits aseptic core regularly to ensure ongoing readiness and compliance.
• Escorts non-gown-qualified personnel as needed.

Education

Bachelor's Degree in Microbiology or Life Sciences

Associates Degree/Certificate in pharmaceutical manufacturing with 1–3 years experience

Job description

Job Summary

Starting Hourly Rate: $25 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.
• 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.

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-w i l l, 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.