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PDDN

Digital Engineer - POMS MES

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeChicago, IL, USANo salary listedRemote

About the Job

Requirements

  • At least 8 years of pharmaceutical or life sciences experience.
  • At least 5 years of POMS MES experience.
  • Strong experience with manufacturing execution systems, electronic batch records, workflows, Good Manufacturing Practice and Good x Practice compliance, and computer system validation.
  • Experience with troubleshooting, documentation, and compliance requirements including FDA 21 CFR Part 11 and GAMP 5.

Responsibilities

  • Configure, support, and implement manufacturing execution system solutions.
  • Bridge business, quality, validation, and information technology functions to ensure compliance and operational excellence.

Desired Qualifications

  • Experience with large-scale manufacturing execution system rollouts.
  • Experience integrating enterprise resource planning, laboratory information management systems, and supervisory control and data acquisition systems.
  • Knowledge of ISA-95.
  • Experience with Agile or hybrid delivery.
  • Experience in global manufacturing.

About the Company

PDDN

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