The MBR designer is responsible for understanding all the complexities of the Client's system, revise and design new electronic batch records, troubleshoot EBR issue and lead continuous improvement initiatives relative to Client's .
This position is also responsible for the overall business process and improvement topics relative to electronic records.
This position is expected to understand the nuances of the highly complicated electronic system.
This position utilizes LEAN tools to systematically evaluate information flow, create project plans and drive right first-time success.
The MBR designer trains modelers to learn how to generate batch records, generates and refines batch record creation training materials and troubleshoots EBRs.
The MBR designer works with client groups (Process Engineers, Operations, Quality) to determine design changes and improvement opportunities within the scope of electronic batch records and leads the team to prioritize and implement said improvements.
This role is required to work with industry experts to stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business.
The MBR designer leads and participates in project teams and works within BioPharma Client's team to standardize business processes.
Skills:
Subject matter expert relative to manufacturing and MES Master Batch Records.
Ability to transform/translate process information/design from process description into a MES Master Batch Record.
Experience working in multiple projects simultaneously.
Technical writing skills.
Technical knowledge of manufacturing systems, methods and procedures, biopharmaceutical manufacturing processes, knowledge of regulatory aspects (cGMP).