Process Validation & Test Engineer

About the role

The ideal candidate will use industry best practices and 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 validation plans and material qualifications as required.

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.
• Initiate engineering change control.
• 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 validation reports.
• Qualify test method fixtures 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.
• Recognize the need for and embrace continuous improvement; create new ideas and recommendations based on engineering data, facts, and observations.
• Collect process data and perform trending and statistical evaluation to monitor process performance, understand stability, and identify areas for improvement.
• Implement changes including initiating change control, performing impact assessment, and evaluating risk for non-conformances or process improvements.
• Identify root cause of failures or deviations to plan and develop corrective actions.
• Effectively partner with and motivate enabling support teams to improve operations for the advancement of the whole site and company.
• Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.

Requirements

• 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.

Skills

• Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries.
• Flexibility and agility to respond to constantly changing conditions and priorities.
• Willingness to quickly learn and become proficient in common systems used to manage the business, including 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.

Pay

The U.S. base salary range for this full-time position is $77,000 to $118,000. The range reflects the base pay target for new hire salaries. 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.

Benefits

• Comprehensive healthcare and insurance benefits beginning on day one.
• 401K plan with a match and profit-sharing contribution from Zoetis.
• 4 weeks of vacation.
• Additional benefits supporting physical, emotional, and financial wellbeing, including family and lifestyle resources.

About Zoetis

At 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. Our award-winning culture focuses on colleagues' careers, connection, and support.