Master Batch Record (MBR) Designer

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Check out what our employees say makes working here so great: Master Batch Record (MBR) Designer will be presented with hard work relentless challenges and the pressure of high expectations. 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.

What You Can Expect:

• Hard work relentless challenges and the pressure of high expectations.
• Generous recognition in times of success yet unwavering support during setbacks.
• A journey that will test your limits and push you to new heights.
• The opportunity to make a significant impact and leave a legacy.
• The camaraderie of a dedicated and passionate team.

Key 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.

Qualifications:

Educational Background

• Required: Bachelors degree in Life Sciences Pharmaceutical Sciences Industrial Chemical Mechanical or Automation Engineering or a related technical field.
• Preferred: MES platform-based training or certification (e.g. Koerber PAS-X Training)
  

Professional Experience

• 3 - 5 years of experience in pharmaceutical manufacturing quality assurance or technical writing with exposure to batch record development.
• Minimum of 2 - 3 years of hands-on design experience with electronic batch record (eBR) systems (e.g. Koerber PAS-X Emerson Syncade Tulip Pharma Suite).
• Proven experience mapping business processes (e.g. Visio or Lucid Chart)
• Knowledge of GMP FDA 21 CFR Part 11 and other relevant regulatory standards.
• Practical experience working in a project environment with a project team.

This role requires a minimum of 3 years of experience in Food Pharmaceutical Animal Health Medical Device or Bio-Pharmaceutical manufacturing industries.

**Apply nowand be part of something extraordinary.**

Pre-Employment Requirements:

• Pass and maintain pre-employment/contract background check and safety certification including outstanding professional references.
• Subject to motor vehicle report review.
• Maintain valid drivers license and endorsements as required per position.
• Pass pre-employment/contract physical medical evaluation and drug screen due to the safety sensitive nature of this position.
• Successfully complete and maintain any required safety certification and testing annually.

• Candidates for positions that include remote or hybrid opportunities must provide their own access to a secure high-speed internet signal (preferably hard wired) at a capacity sufficient to support video web and email processing simultaneously based on their personal work environment. This is typically 100Mb and above.

Key Words:PAS-X GMBR Designer MBR Designer eBR MES