Job Description
Roles & Responsibilities:
Support implementation of a new MES for drug substance manufacturing operations.
Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
Validation and compliance reviews.
Ensure project deadlines and quality performance standards are met for all CSV-related activities.
Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
Review and ap...
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Job Details
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Location
Durham, North Carolina
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Job Type
Full-time
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Category
Computer Occupations
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Posted Date
July 02, 2026
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Application Deadline
August 11, 2026