Master Batch Record (MBR) Designer - 1099/W2

GMP Pros®; Omaha (NE); Hybrid; USD 80,000 - 100,000; Full time

Job summary

GMP Pros® is seeking a Master Batch Record Designer in Omaha, Nebraska, to develop and maintain electronic Master Batch Records within a manufacturing execution system. The ideal candidate will have experience in the biotech or pharmaceutical industries and must understand regulatory standards.

This role offers remote work with occasional on-site requirements. Candidates should possess strong communication skills and experience with eBR systems like PAS-X.

Qualifications

• 3-5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing.
• Minimum of 2-3 years hands-on design experience with eBR systems.
• Knowledge of GMP, FDA 21 CFR Part 11, and relevant regulatory standards.

Responsibilities

• Develop, configure, and maintain electronic Master Batch Records.
• Work with project team to understand business requirements.
• Support integration of hardware and infrastructure.

Skills

Experience in biotech, pharmaceutical, or animal health industries

Hands-on design experience with electronic batch record systems

Mapping business processes (Visio, Lucid Chart)

Excellent communication and organization skills

Analytical and problem-solving mindset

Education

Bachelor’s degree in Life Sciences or related field

MES platform-based training or certification

Tools

PAS-X

Pharmasuite

Siemens opCenter

Job description

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.

Applicants must have prior experience in biotech, pharmaceutical, or animal health industries to be considered.

Essential Duties

• 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.

Additional 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.

Pre-Employment Requirements

• 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.

Work Environment Expectations

• This role can be remote with occasional on‑site work.