Job Description

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.

  • Perform and/or review CSV deliverables including:

  • Documentation requirements.

  • Validation plans and risk assessments.

  • Functional requirements.

  • Configuration specifications.

  • Testing activities.

  • Change control documentation.

  • Traceability matrices.

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