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Job Description:

Pay Range $80hr - $83hr

Responsibilities:
  • Collaborate with Manufacturing, Supply Chain, Quality, Facilities and Tech Transfer departments, capturing and documenting detailed requirements.
  • Perform application support duties for the manufacturing execution system (MES) as needed.
  • Develop standards and best practices for development and validation activities.
  • Lead cross-functional teams through design reviews and user acceptance testing during the development and validation process.
  • Perform and communicate planning, development, peer review, and testing solutions for recipe creation and modification.
  • Execute development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed software solutions.
  • Develop MES solutions including recipe, configuration and/or system changes to meet business requirements.
  • Create and execute system test and/or operational qualification scripts to challenge the business and technical requirements.
  • Participate in facility operational meetings to ensure facility reporting needs are met.
  • Provide mentorship and training for new MES recipe developers.
  • Assure quality customer service to all customers.
Experience:
  • 5+ years in computer or science-based field.
  • Direct experience in Emerson Syncade MES System. Experience in another MES system will be considered.
  • Experience with writing and executing validation protocols.
  • Strong technical writing competency and GMP procedure writing.
  • Strong interpersonal skills to work with teams in different functions and organizations.
Qualifications:
  • Experience with SQL and XML coding in a MES construct. MS Windows Server and SQL server also a plus.
  • Experience with cell therapy or other biopharmaceutical manufacturing. Other highly regulated industries will be considered.
  • Flexibility to work within manufacturing schedules.
  • Experience with Bar Tender label development.
  • Experience with MES-ERP integrations.
  • Experience with new process and product deployments within a MES.
  • Bachelors degree or equivalent experience.

Last updated on Sep 22, 2023

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