Sr. Specialist, Project Leader

Job Post Index 2446F6-Sy##
Location Devens, MA
Description: Description
  • Apply manufacturing process expertise and electronic batch record technical knowledge to own electronic batch record changes and the associated change controls.
  • Own Electronic Batch Record (MES/Syncade) Functional specifications. Ensure consistent execution of recipe modifications and changes. Ensure adherence with governing documents related to change management.
  • Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to ensure change initiatives are driven to closure, and migrated to the production area in a timely manner.
  • Owns the lifecycle of an electronic batch record change
  • Works with site functional teams, including manufacturing, engineering, warehouse and quality assurance to gather user requirements for recipe development.
  • Understanding of MES library objects. Use that understanding to direct changes to MES recipes and/or directly update the MES recipes utilized in Manufacturing.
  • Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
  • Execute testing of the recipes in the development environment to ensure functionality.
  • Manage User Acceptance Testing process or recipe qualification.
  • Provide technical support by troubleshooting and resolving MES issues to support manufacturing operations.
  • Develop and deliver reports from reporting software.
  • Able to use creative problem solving.
  • Provides technical expertise to management and less experienced professionals.
  • Provides input to the design and recipe development for manufacturing electronic batch records (MES).
  • Works with Digital Plant, IT, Manufacturing Operations and process subject matter experts to deliver changes to MES recipes.
Skills: Qualifications
  • Bachelor’s degree in a related field from an accredited college or university required.
  • Minimum of 4 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
  • Excellent project management skills and coordination with stakeholders are needed
  • Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.
  • Minimum of 1 year of experience supporting electronic batch records, preferably Syncade MES.
  • Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting
  • Must be goal-oriented, flexible, and a subject matter expert in electronic manufacturing batch records.

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