29 days old

Business Analyst II

Roche
Vacaville, CA

Purpose:  
Design and maintain Manufacturing Execution Systems (MES) configurations to enable production processing and quality operations, and support the use of these systems at a pharmaceutical bulk drug substance facility to ensure correct synchronizations with the other network business systems.

Job Responsibilities: 
⢠   Initiate, research and resolve events in the manufacturing process and support systems that are deemed outside of approved operating parameters or approved procedures.
⢠   Create, review, approve, test and maintain Systems-related documentation such as: Tickets, Recipe Designs, and System Application Designs that may result in modifications in Level 3 Systems to implement continuous improvement changes and capital projects.
⢠   Use the Electronic Change Management System to implement or correct tickets, recipes or data within supporting systems.
⢠   Test and deploy system changes of new or existing System Designs or Integrations for Manufacturing and Quality Systems.
⢠   Submit software change requests, participate in requirement review meetings, user acceptance testing, and validation testing. 
⢠   Manage Application Vendors and Software Developers in the documentation, investigation, resolution, testing and deployment of solutions for functional product issues.

Provide Level 3 application use, configuration and integrations subject matter expertise for: 
⢠   Discrepancy Management and Resolution
⢠   Recipe and Lot Trace Management
⢠   24X7 Hotline Support for Vacaville Manufacturing groups
⢠   Changeovers, Shutdowns, Product Transfers and Campaign Support
⢠   Validation, Change Deployment and Documentation

Job Requirements:
⢠   Thorough understanding of current Good Manufacturing Practices (cGMPâs) as they apply to support of automation related business systems. 
⢠   Perform all duties and responsibilities in accordance with current applicable Roche Pharma Quallity System docuemtents and departmental procedures. 
⢠   Maintain and support site level 3 MES (ie POMS, POMSnet, Syncade, etc.) by developing and managing site MES master data, performing data analysis and providing business system support.  Configuration experience with MES (ie POMS, POMSnet, Syncade, etc.) is preferred.
⢠   Familiarity with pharmaceutical bulk drug substance manufacturing processes preferred.
⢠   Experience with use of computer-based systems in a validated environment.
⢠   Able to partner with a variety of customers and partners, such as Manufacturing, Technology, and Quality departments.
⢠   Possesses good problem solving, interpersonal, communication (written and verbal), team, and customer service skills.
⢠   SQL statement scripting competency preferred.
⢠   Minimum BS/BA degree. 5-7 years as a business professional in similar job functions or equivalent job experience. Degree or background in computer science is a plus.
 

Posted: 2018-11-20 Expires: 2018-12-20

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Business Analyst II

Roche
Vacaville, CA

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