MES MBR Designer

Responsibilities:

• Excellent employment opportunity for a MES MBR Designer in the Fremont CA area.
• 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.
• Also 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 firsttime success.
• Trains modelers to learn how to generate batch records generates and refines batch record creation training materials and troubleshoots EBRs.
• 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.
• 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.
• Leads and participates in project teams and works within BioPharma BioMES team to standardize business processes.

Experience:

• Professional training or Associates/Bachelors Degree in STEM IT or equivalent.
• 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).
• Schedule: 1st Shift: Monday to Friday 8:00AM5:00PM
  Required Skills: MANUFACTURING PROCESSES BATCH RECORD CGMP TRANSLATE BIOPHARMACEUTICAL
• Additional Skills: WRITING SKILLS SUBJECT MATTER EXPERT BATCH RECORDS OPERATIONS PROJECT PLANS