Process Validation & Test Engineer

POSITION SUMMARY

 The 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.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.