Master Batch Record (MBR) Designer - 1099/W2

About the role

The 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.

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.

Requirements

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field.
• MES platform-based training or certification (e.g. Koerber PAS-X Training) preferred
• 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.

Qualifications

• 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.

Benefits

Join an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

Pay

Compensation is commensurate with experience.

Schedule

This role can be remote with occasional on-site work.