GMP Process Engineer & CAPA Leader

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

Benefits offered by this job

Healthcare and insurance benefits

401K plan with match and profitSharing

4 weeks of vacation

Job summary

Zoetis in the United States seeks a Process Engineer to drive regulatory-aligned requirements, validate processes, and lead qualification activities for consumables used in diagnostic products. The role requires collaboration across cross-functional teams to execute validation plans and ensure timely qualifications.

The ideal candidate has 5+ years in GMP manufacturing, preferably in diagnostics or biodevice industries, with Lean Six Sigma and DOE experience.

Qualifications

• BS in Science or Engineering; Mechanical or Chemical preferred.
• 5+ years' GMP manufacturing experience, preferably in diagnostics or biodevice industries.
• Experience with Lean Six Sigma and RCA methods.
• Ability to use data to influence decisions.

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 for Zoetis diagnostic products.
• Implement changes including change control, impact assessment, and risk evaluation for non-conformances or improvements.
• Assist vendor in completing deviations and CAPAs to meet delivery timelines.
• Develop and execute protocols and reports to quality equipment and processes; use risk-based validation approaches.
• Collaborate with site operations on projects to increase production capacity or achieve productivity savings.
• Support continuous improvement projects.
• Collaborate with procurement to identify and qualify new vendors.

Skills

cGMP understanding

Lean Six Sigma

Project management

Teamwork / independent work

DOE / Design of Experiments

Data-driven decisions

English proficiency

MS Office (Word/Excel/PP)

Education

BS in Science or Engineering

Advanced degree or Process Engineering cert

Job description

Zoetis in the United States seeks a Process Engineer to drive regulatory-aligned requirements, validate processes, and lead qualification activities for consumables used in diagnostic products. The role requires collaboration across cross-functional teams to execute validation plans and ensure timely qualifications.

The ideal candidate has 5+ years in GMP manufacturing, preferably in diagnostics or biodevice industries, with Lean Six Sigma and DOE experience.