Senior Process Engineer – NPI & GMP Manufacturing

Dexian; Maricopa (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Dexian is seeking a Senior Engineer, Process Engineering in Tempe, AZ to lead process development for new products on site. You will support equipment selection, validation, PFMEA, and SOPs while ensuring GMP compliance and collaboration with cross-functional teams.

The role requires 2+ years of related experience, a B.S. in engineering, and preference for Lean Six Sigma Green Belt and FDA-regulated industry experience. This is an onsite, 12+ month opportunity with potential extension.

Qualifications

• 2+ years of relevant work experience
• Bachelor’s degree in engineering
• Lean Six Sigma Green Belt or above preferred
• Knowledge of manufacturing processes and design for manufacturing
• Experience in FDA-regulated industry preferred

Responsibilities

• Provide engineering support for new product introductions and process development.
• Ensure quality of process and product per specifications.
• Assist in equipment selection and design based on specs and reliability.
• Support capital projects including equipment specs, contracts, installation, and validation.
• Write operations manuals and maintenance documents.
• Conduct PFMEA, control plans, SOPs, and PPAP for transfers/ launches.
• Perform capability studies and validation MSAs.
• Train manufacturing team and ensure GMP and safety compliance.

Skills

Manufacturing processes

DFM

Statistical methods

Validation techniques

Process engineering

Education

Bachelor's degree in engineering

Industrial or Systems Engineering degree preferred

Job description

Dexian is seeking a Senior Engineer, Process Engineering in Tempe, AZ to lead process development for new products on site. You will support equipment selection, validation, PFMEA, and SOPs while ensuring GMP compliance and collaboration with cross-functional teams.

The role requires 2+ years of related experience, a B.S. in engineering, and preference for Lean Six Sigma Green Belt and FDA-regulated industry experience. This is an onsite, 12+ month opportunity with potential extension.