Summary:

This role will execute engineering duties within the Operations Engineering organization. Ensures engineering readiness to support production and product transfer activities. Works within company Quality Management System.

Responsibilities:

• Executes installation, setup and qualification of manufacturing equipment.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols and reports, risk assessments, and procedures and other technical documents to insure compliance, efficient and safe procedures.
• Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process.
• Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
• Research engineering solutions to a diverse set of challenges in production and development.

Must Haves:

• HS/GED required. Looking for 5+ years of experience.
• Manufacturing background will be helpful.
• Experience working in regulated industry.
• MS office (Excel, Word) experience.
• Validation of equipment, IQ  is primary focus.
• Hand on/Okay working in cleanroom environment.

Plusses:

• AutoCAD is a plus.
• MES experience will be a plus.

• Lean Six Sigma, MS Suite; Excel and WRD, Tech background… knowledgeable of MES.