MES Recipe Author
REMOTE, RI 00000 US
The Manufacturing Execution Systems Recipe Author will provide functional development and technical support to all MES implementations and optimization projects for Cell and Gene Therapy Division.
• Author new recipes, unit procedures and worksheets in POMSnet Aquila MES system.
• Modify existing recipes and worksheets as manufacturing process changes and optimizations are requested.
• Be a technical lead for integrating POMS with other software packages including Oracle, CMMS, LIMS and others.
• Collaborate with business stakeholders to understand their current and future state strategy, needs and requirements.
• Create custom reports or queries needed by the business.
• Provide input and testing requirements for system validation team.
• Author or provide input for system documentation and training materials.
• Facilitate workshops and discussions to provide answers to key design decisions.
• Partner with cross functional team members and Data, Technology and Engineering (DTE) peers for platform, database, and peripheral support.
• Ensure compliance with GMP regulations, data integrity, system lifecycle, and change management requirements.
• Recipe authoring in POMSnet Aquila software.
• In depth understanding of POMS phases and object-based programming.
• Ability to code PTL in C# or other available language.
• Able to convert business requirements into working recipes and worksheets.
• Work with end users to review system capabilities, design options and tradeoffs.
• Understanding of validated system life cycles.
• Working in Medical, Pharmaceutical, or Biotech GMP environments.
• Strong communication, interpersonal and collaborative skills.
• Solid analytical and problem-solving abilities.
• Position can be remote, with some travel to Boston area for major system updates or go-live events.
PREFERRED EDUCATION AND EXPERIENCE:
• Bachelor’s degree in computer science, Engineering, or related fields.
• Minimum of 3 years of experience as a recipe author.
• This is a remote role. There will be some travel to the Greater Boston area needed to support program workshops and go-live events.
*CO/NYC candidates might not be considered
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