MES Technical Writer

Responsibilities:

• Excellent employment opportunity for a MES Technical Writer in the Fremont CA area.
• Responsible for understanding all the complexities of the MES system revise and create SOPs test protocols technical documents such as design specifications training materials and process flow maps.
• Expected to have EBR design experience and lead continuous improvement initiatives relative to MES.
• The technical writer is also responsible for leading end user trainings and improvement topics relative to MES.
• In addition the technical writer leads and participates in project teams and works within BioPharma BioMES team to standardize business processes.
• This position utilizes LEAN tools to systematically evaluate information flow create project plans and drive right firsttime success.
• The technical writer is also expected to understand the nuances of the highly complicated electronic system.

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 and process flow maps.
• Experience working in multiple projects simultaneously.
• Proficiently construct clear and consistent documents.
• 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: PROCESS FLOW MANUFACTURING PROCESSES BATCH RECORD CGMP VISUAL INSPECTION
• Additional Skills: TRANSLATE BIOPHARMACEUTICAL SOPS SUBJECT MATTER EXPERT BATCH RECORDS PROJECT PLANS