Gmppros

Gmppros

Master Batch Record (MBR) Designer - 1099/W2

Omaha, Nebraska, United States

Sponsorship not specifiedDetected 28 days ago
GMPFDA RegulatoryCommunicationProblem SolvingWriting

About the role

  • Do you need variety and change to keep from getting bored?
  • Do you like working in a team supportive environment where others want to help you succeed?
  • Do you try to find a better way for everything because that is the way it should be?

Responsibilities

  • Work with a project team to understand business requirements for design and deployment of PAS-X across manufacturing and packaging for Oral Solids Dosage.
  • Take design blueprints and translate into GMBRs, MBRs, PMBRs, PVLs, and ESPs for the deployment.
  • Support the creation and management of Master Data.
  • Support integration of hardware and infrastructure (printers, scanners, clients).
  • Test and troubleshoot designs with end users in the DEV environment.
  • Support verification and validation of designs in the PROD environment.
  • Support Early Life Support and Hyper Care for deployment activities across the site.
  • Maintain project deliverables and milestone dates.
  • Do you build relationships easily and are you able to communicate information so that it is easily understandable?
  • The MBR Designer is responsible for developing, configuring, and maintaining electronic Master Batch Records within a manufacturing execution system (MES) to support compliant and efficient production.

Requirements

  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
  • 5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with exposure to batch record development.
  • Proven experience mapping business processes (e.g. Visio or Lucid Chart)
  • Knowledge of GMP, FDA 21 CFR Part 11, and other relevant regulatory standards.
  • Ability to multi-task and complete multiple projects on time.
  • Maintain valid driver's license and endorsements as required per position.

Nice to have

  • MES platform-based training or certification (e.g. Koerber PAS-X Training) preferred
  • 3 years of hands-on design experience with electronic batch record (eBR) systems such as PAS-X, Pharmasuite, Siemens opCenter, etc. (PAS-X preferred).

Compensation

  • Successfully complete and maintain any required safety certification and testing on an annual basis.

Benefits

  • Be part of an exciting start-up that supports the world's leading pharmaceutical, biotech, food, and animal health companies.
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