Jobs · Consulting · Texas

MES Consultant (x2)

Planet Pharma · Austin, TX · 3 wk ago
ConsultingContract

About the role

Our client is seeking two contractors to update approximately 300 controlled manufacturing documents during their transition from paper-based processes to Siemens Opcenter, a new Manufacturing Execution System. This is a high-priority, multimillion-dollar implementation with firm deadlines, and the consultants are expected to start as soon as possible.

Responsibilities

  • Review and revise approximately 300 manufacturing work instructions and procedures to support both the existing paper process and the future Siemens Opcenter workflow.
  • Preserve current paper-based instructions in an appendix for use when the MES is unavailable.
  • Replace generic references with clear instructions for completing each step in Opcenter.
  • Apply standardized language consistently across all documents.

Requirements

  • Senior-level GMP technical writing experience (must be a strong writer).
  • Experience revising controlled manufacturing documents and work instructions.
  • Medical device manufacturing experience, ideally with knowledge of traceability requirements.
  • Sufficient manufacturing or engineering knowledge to understand production processes.
  • Familiarity with MES environments or electronic manufacturing workflows.
  • Ability to understand why information is being captured and translate technical requirements into clear instructions.

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