Process Validation Engineer – Medical Diagnostics

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

Benefits offered by this job

Short-term incentive compensation

Healthcare benefits starting day one

401K with match and profit-sharing

Vacation 4 weeks

Job summary

Zoetis seeks an experienced Validation/Quality professional to lead CAPA investigations, plan material and process qualifications, and support instrument manufacturing in a busy on-site environment.

You will establish validation standards, develop V&V protocols, and coordinate with vendors to finalize reports, while driving continuous improvement through data-driven actions and cross-functional collaboration.

Qualifications

• Bachelor's Degree in BioEngineering / Chemistry or related fields with 3+ years of manufacturing experience.
• Experience in regulated industries (FDA/USDA) required.
• Experience with software validation is a plus.

Responsibilities

• Lead nonconformance investigations and drive CAPA using RCA and Lean Six Sigma.
• Plan and execute material and process qualifications and spreadsheet validations.
• Support instrument manufacturing and troubleshoot process issues.
• Represent the process and validation group in cross-functional meetings.
• Establish validation standards and develop V&V test protocols; document results.
• Coordinate with vendors to define validation requirements and approve final reports.
• Create and maintain project timelines including risk mitigations.
• Drive continuous improvement through data-driven insights and action.
• Perform root-cause problem solving and implement preventive actions.
• Collaborate with enabling support teams to improve site operations.

Skills

CAPA investigations

Root cause analysis

Lean Six Sigma

Regulatory compliance

Statistical analysis (JMP/Minitab)

ERP systems (SAP)

Excel / Office tools

Education

Bachelor's Degree in BioEngineering / Chemistry or related fields

Tools

SAP

JMP

Minitab

MS Visio

Excel

Word

Job description

Zoetis seeks an experienced Validation/Quality professional to lead CAPA investigations, plan material and process qualifications, and support instrument manufacturing in a busy on-site environment.

You will establish validation standards, develop V&V protocols, and coordinate with vendors to finalize reports, while driving continuous improvement through data-driven actions and cross-functional collaboration.