MBR DesignerMedical WriterFremont, CA, USPay Rate Low: 100 | Pay Rate High: 106
Added - 27/03/2024
Apply for JobOur client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Master Batch Record Designer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!1st Shift: Mon-Fri, 8:00AM-5:00PMJob Description: Responsible for understanding all the complexities of the BioMES system, revise and design new electronic batch records, troubleshoot EBR issue and lead continuous improvement initiatives relative to BioMES. Responsible for the overall business process and improvement topics relative to electronic records. 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 BioMES 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).
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
