GMP Process Engineer: CAPA & QA Improvement Lead

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

Benefits offered by this job

Healthcare benefits from day one

401K with match

Profit-sharing

4 weeks vacation

Job summary

Zoetis is seeking a qualified Process Engineer to measure and specify requirements for best-in-class quality products and manufacturing design. The role requires cross-functional collaboration to execute validation plans and material qualifications as needed.

The candidate will lead CAPA investigations, support manufacturing troubleshooting, and drive optimization of consumables for Zoetis diagnostic products, with emphasis on risk-based validation and change control.

Qualifications

• BS in Science or Engineering or equivalent years of experience in Process Engineering.
• 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 (e.g., 5-Why, fishbone, fault tree) and Lean Six Sigma tools.
• Support manufacturing and troubleshoot process related issues.
• Lead projects relating to the development and optimization of consumables used in Zoetis' diagnostic products, ensuring deliverables and project timelines are met (30%).
• 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.
• Use risk-based approaches for validation strategies, including acceptance criteria and sample sizes.
• 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

GMP manufacturing

Lean Six Sigma

cGMP knowledge

Project management

Data-driven decisions

Communication skills

English proficiency

DOE

Education

BS in Science or Engineering

Advanced degree or training in Process Engineering

Tools

Microsoft Office

DOE

Job description

Zoetis is seeking a qualified Process Engineer to measure and specify requirements for best-in-class quality products and manufacturing design. The role requires cross-functional collaboration to execute validation plans and material qualifications as needed.

The candidate will lead CAPA investigations, support manufacturing troubleshooting, and drive optimization of consumables for Zoetis diagnostic products, with emphasis on risk-based validation and change control.