Process Validation & Test Engineer

Job description

POSITION SUMMARY 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 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 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 including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation. Visit zoetisbenefits.com to learn more. 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. Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications. 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.