What are the responsibilities and job description for the GMT Senior/Staff Engineer position at Zoetis?
States considered: Michigan
Role Description
The Validation Engineer is responsible for assuring that site validation meets current regulations, corporate quality standards and local QA procedures. Specific validation disciplines may include equipment qualification, water/qualified utility/HVAC qualification, facility qualification, automation qualification, process validation, cleaning validation, sterilization etc. The individual will be the site validation subject matter expert (SME) for site customers and will support regulatory audits. Other responsibilities include:
RESPONSIBILITES
- Manage validation documents (Create/review/approval test protocols).
- Creation of validation documentation and authoring/maintenance of validation SOP’s.
- Maintenance of the site validation master plan in compliance with relevant quality standards and regulations.
- Supporting the change control process and performing risk assessments.
- Periodic review of validated systems as part of the validation life cycle and providing validation assessments as needed and ongoing process verification of manufacturing processes.
- Ensure validation documentation is appropriately stored and cataloged for retrieval.
- Provide support in managing CAPA activities for the team.
- Track/manage due date of compliance items (CAPAs, Deviations, Periodic Reviews, Change Control). Submit extension requests as required.
- Provide audit support for various regulatory agencies.
- Interface with capital projects to ensure proper identification, verification / validation of new & changed equipment.
- Support CAD and Engineering teams to ensure accuracy of drawings and documentation submittals.
- Assist with generating governing verification strategy for both expense and capital projects, risk assessments (Quality/Business).
- Manage documentation to reflect current design based on capital/expense projects. Documentation includes:
EDUCATION AND EXPERIENCE
- Bachelor’s degree with 5 years of experience, or a Master’s Degree with 3 years of experience. Science-related degrees preferred.
- A minimum of 5 years relevant validation experience is preferred, specifically with cleaning or sterilization validation. Other pharmaceutical backgrounds will be considered.
- Must possess a working knowledge of validation documentation practices.
- Must be proficient in relevant computer software.
- Minimal lifting required, extended sitting periods expected.
- Minimal travel time expected (<5%).
NOTE: Candidates must not be Cephalosporin/Penicillin sensitive.
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.
