Process Validation & Test Engineer

POSITION SUMMARY

This main responsibilities for this position will be:

• Material and process qualifications
• Support Instrument (Medical Diagnostics Device) manufacturing and troubleshoot process related issues
• Test, validate, and troubleshoot electrical or mechanical components for point of care Instruments (Medical Diagnostics Device)
• Validate the systems and software used to develop or manufacture instruments and/or assay consumables used within instrumentation.
• Initiate engineering change control

The ideal candidate will use industry 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 manufacturability. 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.

IMPACT AND ORGANIZATIONAL CONTRIBUTION

• Work with end users to develop consumable/assay/machine/software design specifications including user requirements specifications for all applications.
• 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.
• Develop/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.
• Work with the Quality organization to optimize preventative maintenance and calibration process based on the validation requirements/plan.
• Utilize statistical tools, to determine whether the systems, process or materials meet requirements.
• 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 Mechanical/Electrical Engineering with 3+ years of experience in a manufacturing environment
• Experience in regulated industries (Food and Drug Administration, USDA) is required.
• Ability to read/understand/create drawings and schematics.
• Experience with Microsoft Excel (VBA programming) and SolidWorks is a plus.
• Experience with software validation is a plus.
• Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries.
• Candidate 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.
• Experience with Non-Conformance report (NCR) and Corrective Action and Preventative Action (CAPA) is preferred.
• Experience with operating and programming CMM (Coordinate Measuring Machines) is preferred.
• Experience with injection molded plastics is preferred.
• Experience dealing with outside vendors or CMOs is preferred.

Work Environment: Colleague must work onsite, be able to lift at least 50 pounds, and work near moving mechanical parts with moderate noise level where the use of hearing protection is optional, and eye protection is required.

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in [California] Base pay may vary based on location and other factors.

Base Pay Range: $73,000 - $112,000

This position is eligible for short-term incentive compensation.

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.

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. 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.

Diversity, Equity & Inclusion

Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.

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