Master Batch Record (MBR) Designer - 1099/W2

GMP Pros, Inc. • Omaha, NE

2d • Remote

About The Position

The Master Batch Record (MBR) Designer will be responsible for developing, configuring, and maintaining electronic Master Batch Records within a manufacturing execution system (MES) to support compliant and efficient production. This role is part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies, offering the benefits of working on projects for global pharmaceutical companies while enjoying the flexibility and energy of a small, close-knit company. Applicants must have prior experience in Biotech, Pharmaceutical, or Animal Health industries to be considered.

Requirements

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
• 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 such as PAS-X, Pharmasuite, Siemens opCenter, etc. (PAS-X preferred).
• 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.
• Experienced in an FDA-regulated environment.
• Excellent communication and organization skills, with an analytical and problem-solving mindset.
• Ability to multi-task and complete multiple projects on time.
• Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
• Subject to motor vehicle report review.
• Maintain valid driver’s 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 on an annual basis.

Nice To Haves

• MES platform-based training or certification (e.g. Koerber PAS-X Training) preferred

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level