MES Consultant

Important clarification:

This is not a traditional eQMS role. It is a manufacturing focused documentation project centered on production workflows and system inputs and outputs. The initial scope is limited to document updates, although one or both consultants may support additional projects depending on their experience and internal approval.
Job Description:

• Our client is looking to add two contractors to update approximately 300 controlled manufacturing documents as the company transitions from paper based processes to Siemens Opcenter, its new Manufacturing Execution System. This is an urgent, multimillion dollar implementation with firm deadlines, and they would like the consultants 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 MES is unavailable.
• Replace generic references with clear instructions for completing each step in Opcenter.
• Apply standardized language consistently across all documents

Ideal background:

• 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.