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Validation Engineer

  • Anywhere

Company :
Zoetis Animal Health

Location :
Union City, California

Expiry Date :
Sun, 07 Mar 2021 23:59:59 GMT

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Description :
POSITION SUMMARY This position will be responsible for material qualifications and validating the systems used to develop or manufacture instruments and/or assay consumables used within instrumentation. 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 the Quality Organization to create/optimize a Master Validation Plan. – Work with end users to develop machine design specifications including user requirements specifications for equipment – Establish validation standards, support equipment/process requirements, develop test protocols, lead pFEMA generation and effectively document results through the validation report. – Coordinate with Suppliers to create validation/material qualification requirements, review, and approve final reports. – Create 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, such as MiniTab, 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 – Bachelors Degree in Mechanical, Electrical, Chemistry, Biology, and/or Physics with 7+ years of experience in a manufacturing environment. – Food and Drug Administration, USDA and/or Drug Product Formulation & Aseptic Manufacturing experience is required. – 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, and change control. 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. Full time Regular Colleague 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 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 site, or (2) via email to/from addresses using only the Zoetis domain of @. 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.