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MES WERUM Architect
Location: Bay Area
Posted: June 28, 2020

Job Description

  • MES Application administration for COE DEV, QUAL and Staging environments, including security role configuration / updates.
  • Configures Master Data in Werum, updates master data as per needs based on a spreadsheet provided by a team.
  • Learn automation scripts to enter master data into MES.
  • Writes procedure and performs migration of data from Dev to QA to Production.
  • Performs MES peripherals setup and troubleshooting (Scanners, Weigh Scale, Cell Viability Counters).
  • User Interface setup, Pas X clients.
  • Ensures high uptime of the environment by performing routine system maintenance, advises on what should be done.
  • Troubleshoots EBR execution and BRR reports; Writes disaster recovery/business continuity procedure and prototypes.
  • Authors assigned System SOP's / modifies system SOP's to meet COE needs Create as-built design specifications for the system, that is not provided by Werum (architecture diagrams, as-built detailed specifications for a system such as service configurations etc.)
  • Performs activities to prototype new capabilities, for example builds Nucleo Counter integration solution.
  • Provides production rollout and Hypercare support to the sites, as sites rollout occur.
  • Works on MBR design and documentation as needed in a team environment.
  • Is knowledgeable about Werum system components such as JBoss App servers and database.
  • Provides hands on support to werum issues as they arise at COE, at site rollouts or during Hypercare at site.

Job Type: Full-time

Sr. Veeva Consultant
Location: Newark, NJ
Posted: June 20, 2020

Job Description

Responsibilities
  • Meeting with clients to understand business processes and pain points
  • Advising clients on industry best practices
  • Transforming workshop input into requirement documents
  • Configuring new Veeva workflows, streamlining current workflows
  • Creating reports and formatted outputs
  • Creating and executing validation documents
  • Preparing and executing training
  • Managing smaller projects
  • Identifying and following-up on tasks, actions, risk, issues
  • Ensuring that compliance requirements and quality procedures are met
  • Working with an internal global team on continuous improvement for the Veeva Powerhouse

Skills
  • Proven experience in implementing or supporting the Veeva Quality Suite (QualityDocs, QMS, and Training)
  • Excellent written and verbal communication
  • Knowledge of Quality System regulations and the drug development process including Quality Management System, Document Controls, Quality Records)
  • Experience in Computer System Validation
  • Prior experience in the Life Sciences industry
  • Strong knowledge of GxP compliance and associated controls within the software development lifecycle
  • Project management experience is a plus
  • Previous consulting experience is a plus

Job Type: Full-time

Salary: $50.00 to $70.00 /hour