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.