Process Engineer - GMP Diagnostics & CAPA Lead

zoetis; Union City (CA); On-site; USD 77,000 - 118,000; Full time

Job summary

Zoetis in the United States is seeking a Process Engineer to apply regulatory and industry best practices to measure, analyze, and specify requirements for high-quality products and manufacturing designs.

The role involves cross-functional work to execute validation plans and material qualifications, with a focus on CAPA, change control, and risk assessment to improve processes and equipment used in diagnostic products.

Qualifications

• BS in a field of Science or Engineering (Mechanical and Chemical preferred) or equivalent years of experience in Process Engineering.
• Relevant advanced degree or training / certification in Process Engineering preferred.
• 5+ years' experience in GMP manufacturing, preferably in diagnostics or biodevice industries.

Responsibilities

• Lead nonconformance investigations and drive CAPA using structured RCA and Lean Six Sigma tools.
• Support manufacturing and troubleshoot process related issues.
• Lead projects related to development and optimization of consumables used in Zoetis' diagnostic products, ensuring deliverables and timelines are met.
• Implement changes including initiating change control, performing impact assessment and evaluating risk for non-conformances or process improvements.
• Assist vendor in completing deviations, CAPAs to meet delivery timelines.
• Develop and execute protocols and reports to quality equipment and processes with risk-based validation strategies.
• Collaborate with site operations on projects to increase production capacity or deliver productivity savings of consumable components.
• Support continuous improvement projects.
• Collaborate with procurement to identify and qualify new vendors.

Skills

cGMP knowledge

Lean Six Sigma

Project management

DOE

Data-driven decisions

English proficiency

Microsoft Office

Education

BS in Science/Engineering

Advanced degree in Process Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Zoetis in the United States is seeking a Process Engineer to apply regulatory and industry best practices to measure, analyze, and specify requirements for high-quality products and manufacturing designs.

The role involves cross-functional work to execute validation plans and material qualifications, with a focus on CAPA, change control, and risk assessment to improve processes and equipment used in diagnostic products.