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Freseniusglobal4 days ago

Electronic Batch Record Specialist

$70,000–$85,000 year

On-site · Melrose Park, Illinois, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Maintenance, compliance and change control of the electronic batch records generated through the PAS-X system at the Melrose Park site. Responsible for creating Electronic Batch Record templates and Product Batch records, ensuring timely generation of executable electronic batch records to the shop floor, and integrating PAS-X with SAP and Documentum. Includes coordinating KPI monitoring, SOP reviews and revisions, continuous improvement activities related to Electronic Batch Records, and ensuring proper automation of documentation through manufacturing equipment data. Also involved in ISO 50001 energy management system maintenance and energy-savings recommendations. Requires a Bachelor’s Degree in engineering, IT, computer science or related disciplines; experience with programming or configuring a workflow automation platform (preferably in pharma); experience with aseptic and terminally sterilized parenteral drugs; databases; and virtual machines.

Required Qualifications

  • Bachelor’s Degree in engineering, IT, computer science or related disciplines
  • Experience with programming or configuring a work flow automation platform preferably in the pharmaceutical industry
  • Experience with manufacturing of Aseptic and Terminally Sterilized parenteral drugs
  • Experience with Databases
  • Experience with Virtual Machines
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$70k – $85k / yr

Electronic Batch Record Specialist · Freseniusglobal

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