MES Technical Writer - Sigma Inc

• The MES technical writer is 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.
• This position is 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 first-time success.
• The technical writer is also expected to understand the nuances of the highly complicated electronic system.

• Professional training or Associates/Bachelor's 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).

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