Master Batch Record (MBR) Designer - 1099/W2

Summary

GMP Pros® is an exciting start-up that supports leading pharmaceutical, biotech, food, and animal health companies. The Master Batch Record (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.

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

Skills

• 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
• 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
• MES platform-based training or certification (e.g. Koerber PAS-X Training)
• Experience in an FDA-regulated environment

Qualifications

Must Haves

• 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
• 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)
• Experience in an FDA-regulated environment