Process Engineer

Job Summary

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.


Hourly Rate: $23.45/hour + $3.00 shift differential & 11.1% shift premium

Shift Hours: Friday-Sunday (6PM-6:30AM)

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

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.
• Reports metrics and trends to site management on a regular basis.
• Assumes additional duties and responsibilities as assigned.

Requirements

• Bachelor's Degree in Microbiology or Life Sciences, or a Certificate with a focus on pharmaceutical manufacturing, or converted years of experience as an Aseptic Control Operator and qualified trainer (see conversion table below)
• 2 years of Aseptic Processing experience, including proficiency in Aseptic Gowning, and working 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, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.