Senior Process Engineer II – Lean & Validation

DiaSorin; Austin (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Diasorin in Austin seeks a Process Engineer II to lead manufacturing process improvements, drive cost efficiency, and support scalability through data-driven decisions. You will collaborate across Instrument Production, Quality Control, and Depot operations while applying Lean, Six Sigma, and DOE methods.

Key focus areas include developing robust processes, validating protocols (IQ/OQ/PQ), and mentoring teams to sustain best practices and regulatory compliance in a fast-paced environment.

Qualifikationen

• Bachelor's degree in Industrial, Manufacturing, Mechanical Engineering or related field.
• Master's degree in Engineering preferred.
• 5+ years of process/manufacturing engineering experience in a regulated industry preferred.
• 3+ years of GMP/FDA regulated or ISO certified environment required.

Aufgaben

• Lead and manage complex process improvement projects.
• Identify process inefficiencies and drive measurable improvements with cost, quality, and throughput outcomes.
• Champion and mentor Lean and Six Sigma principles to improve yield, equipment capacity, and factory capability.
• Own and execute process validation protocols (IQ/OQ/PQ) with cross functional alignment.
• Develop and train teams on SOPs to drive process consistency.

Kenntnisse

Lean Six Sigma

DOE

SPC

Root cause analysis

Ausbildung

Bachelor's in Industrial/Manufacturing/Mechanical Engineering

Master's in Engineering

Tools

Excel

MS Office

Visio

Jobbeschreibung

Diasorin in Austin seeks a Process Engineer II to lead manufacturing process improvements, drive cost efficiency, and support scalability through data-driven decisions. You will collaborate across Instrument Production, Quality Control, and Depot operations while applying Lean, Six Sigma, and DOE methods.

Key focus areas include developing robust processes, validating protocols (IQ/OQ/PQ), and mentoring teams to sustain best practices and regulatory compliance in a fast-paced environment.