GMP Process Engineer – CAPA & Lean Six Sigma

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

Benefits offered by this job

Healthcare benefits

401K with match

4 weeks vacation

Job summary

Zoetis in California is seeking a Process Engineer to apply industry best practices and regulatory knowledge to measure, analyze, and specify requirements that drive quality and manufacturability.

You will lead nonconformance investigations, drive CAPA with RCA and Lean Six Sigma, support manufacturing, and manage change controls and risk assessments. The role requires a BS in Science/Engineering, 5+ years GMP experience, and strong English communication.

Qualifications

• BS in Science or Engineering (Mechanical/Chemical preferred); equivalent experience in Process Engineering.
• Advanced degree or certification in Process Engineering preferred.
• 5+ years in GMP manufacturing, preferably diagnostics/biodevices.

Responsibilities

• Lead nonconformance investigations and drive CAPA using RCA and Lean Six Sigma tools.
• Support manufacturing and troubleshoot process-related issues.
• Lead projects for development and optimization of consumables used in diagnostic products; ensure timelines.
• Implement changes via change control, impact assessment, and risk evaluation.
• Assist vendors in deviations and CAPAs to meet delivery timelines.
• Develop and execute protocols and reports for quality equipment and processes; apply risk-based validation strategies.
• Collaborate with site operations to increase production capacity or save costs on consumables.
• Support continuous improvement projects and collaborate with procurement to qualify new vendors.

Skills

cGMP knowledge

Lean Six Sigma

Project management

data-driven decisions

teamwork

communication (written/oral)

English proficiency

MS Office

statistical analysis (DOE)

Education

BS in Science/Engineering

Advanced degree or cert in Process Eng

Job description

Zoetis in California is seeking a Process Engineer to apply industry best practices and regulatory knowledge to measure, analyze, and specify requirements that drive quality and manufacturability.

You will lead nonconformance investigations, drive CAPA with RCA and Lean Six Sigma, support manufacturing, and manage change controls and risk assessments. The role requires a BS in Science/Engineering, 5+ years GMP experience, and strong English communication.