Process Validation & Test Engineer

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

The ideal candidate will use industry's best practices and their expertise in regulatory requirements to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturing. We are looking for a highly motivated candidate, who can work cross-functionally to execute to the validation plan as well as material qualifications that come up as required.

POSITION RESPONSIBILITIES

• Lead nonconformance investigations and drive CAPA using structured RCA (e.g., 5-Why, fishbone, fault tree) and Lean Six Sigma tools.
• Plan and execute Material and process qualifications, spreadsheet validations
• Support Instrument (Medical Diagnostics Device) manufacturing and troubleshoot process related issues
• Represent the process & validation group in cross functional meetings.
• Establish validation standards, support equipment/software/process requirements, develop V&V test protocols, lead pFMEA generation and effectively document results through the validation report.
• Qualify test methods fixtures to be able to test new/alternate components or troubleshoot issues.
• Coordinate with vendors/suppliers to create validation/material qualification requirements, review, and approve final reports.
• Create and maintain project timelines for validations/material qualifications that include risk mitigations to achieve required timelines.
• Recognizes need for and embraces concept of continuous improvement. Creates new ideas and recommendations based on engineering data, facts, and observations.
• Collects process data and performs trending and statistical evaluation to monitor process performance to understand stability and areas for improvement.
• Implement changes including initiating change control, performing impact assessment and evaluating risk for non-conformances or process improvements.
• Ability to identify root cause of failures or deviations to plan and come up with corrective actions.
• Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
• Strong ability to do root-cause problem solving, and implementation of effective preventative action.
• Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.

EDUCATION AND EXPERIENCE

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

TECHNICAL SKILLS REQUIREMENTS

• Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries.
• Candidates must possess flexibility and agility to respond to constantly changing conditions and priorities.
• Must be willing to quickly learn and become proficient in common systems used to manage the business - to include production schedule, quality deviations, ERP system(SAP preferred), and change control.
• Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software

Work Environment: This position requires on site presence in a manufacturing environment. Physical requirements include the ability to lift up to 50 pounds, stand or walk for extended periods, and work in areas with moving mechanical parts and varying noise levels. Personal protective equipment (PPE) is required in accordance with facility safety protocols, which may include safety glasses, hearing protection, steel-toed footwear, and other equipment as designated by area-specific requirements.

The U.S. base salary range for this full-time position is $77,000 to $118,000. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

This position is also eligible for short-term incentive compensation.

In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families.

• healthcare and insurance benefits beginning on day one
• 401K plan with a match and profit-sharing contribution from Zoetis
• 4 weeks of vacation

Visit zoetisbenefits.com to learn more.

About ZoetisAt Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.