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TalentBurst

TalentBurst is hiring: Manufacturing Execution System Recipe Author in Hillsboro

TalentBurst, Hillsboro, OR, United States, 97104

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Title: Manufacturing Execution System Recipe Author, Req#: ROCGJP00029090
Location: Hillsboro, OR (100% onsite)
Duration: 10+ months Contract (by the end of the year)

Job Description:

The role will support Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, which is a Drug Product manufacturing facility (Component Prep & Compounding, Liquid/Lyophilized Filling, automated/Manual Inspection, Packaging/Finished Products and Distribution.) This role would perform Recipe Author activities for the operations that utilize MES in support of Tech Transfer projects.

Responsibilities:

  • Manufacturing Execution System (MES) (PharmaSuite) recipe authoring and software development
  • Troubleshooting plant floor MES execution and business system integration issues
  • Compliance with corporate and site business processes, valid design principles, and quality procedures
  • Qualification test plan development/review/approval and execution
  • Implementing production tech transfer requirements into the MES system
  • Knowledge of batch record structure and exception handling, with sharing among the broader project team and affected site personnel
  • Understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, and project deliverables such as project and implementation plans
  • Development of recipe and workflow requirement specifications, formal design specifications of system master data configuration
  • Create, as directed by the client, project-specific documentation required for implementation
  • Creation and finalizing recipe requirement specifications for all recipes and workflows
  • Contributing to the development and optimization of departmental and site business processes
  • Provide consulting with Business Process owners in the Value Streams
  • Contribute with MES Recipe Authoring knowledge to Projects/Squads for MES Projects, process improvement initiatives or support

Qualifications / Requirements:

  • A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
  • A minimum of 5 to 7 years of manufacturing execution systems experience, preferably PharmSuite
  • Strong interpersonal communication skills
  • Project management skills
  • Ability to multi-task while handling routine and impromptu assignments with minimal supervision
  • Must be able to plan and perform testing, including documenting test conditions, expected results, and test validation
  • Must be comfortable working under pressure, delivering quality results with schedule deadlines, and have a proven track record in meeting schedule for tasks while still meeting or exceeding business requirements and goals
  • Work autonomously directly with Engineering and Value Streams
  • Work with the Global Recipe Authors Team on common templates for PharmaSuite MES
  • Job duties include hours on-call support at least one week a month
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