Equipment Validation Specialist

re

Zoetis is the worlds largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln NE we manufacture high quality medicines for dogs cats and livestock. Our plant has been recognized as one of the Nebraskas Safest Companies with a long-standing presence in the Lincoln community. We are a clean modern site that continues to innovate and grow.

Benefits Include:

$500 Sign on Bonus

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health personal and family benefits starting day 1.

Position Summary

The Equipment Validation Specialist is a new role that will be primarily focused on equipment validation periodic reviews and report to the Validation Program Manager. Periodic review plays a critical role in the validation lifecycle serving as the bridge between initial equipment qualification and ongoing compliance assurance. The successful candidate will perform comprehensive equipment assessments analyze equipment performance data write periodic review summary reports and manage the periodic review scheduling.

Hours: 1st Shift. Overtime and weekend work may be required.

Position Responsibilities

• Periodic review equipment performance against validated state
• Physical evaluation of equipment to verify operational conditions including visual inspection and occasional surface sampling for laboratory analysis
• Author equipment validation periodic review reports
• Manage the equipment schedule for periodic review.
• Initiate investigations upon discovery of validation discrepancies.
• Support regulatory agency customer and internal audits.
• Maintain cGMP compliance with department Standard Operating Procedures (SOPs) Zoetis Quality Standards and 21CFR EU and other regulatory guidelines.
• Review and approval of ETS action items / commitment tracking items
• Perform documentation review.
• Participate in change management activities.
• Other responsibilities as assigned.

Education and Experience

Required:

• 2-year degree/certificate in an engineering or science-based field
• 5 Years of experience working in a cGMP / regulated environment

Preferred:

• 4-year degree/certificate in an engineering or science-based field

Technical Skills and Competencies Required

Required:

• Strong technical writing ability
• Verbal and written communication skills (fluent in English)
• Functional knowledge of internal and external requirements associated with equipment validation.
• Demonstrated ability to establish appropriate timelines to meet key milestones with minimal supervision.
• Investigation and Problem Solving
• Ability to analyze data and draw scientific conclusions.
• Work effectively in a cross-functional and team-based environment.

Preferred:

• Project management / leadership experience
• Six Sigma Green Belt certification
• Demonstrated ability to escalate issues.

Physical Position Requirements

• This position requires sitting standing and walking with potential for occasional overtime/weekend work.
• Lift materials up to 40lbs
• Wearing appropriate PPE / gowning.

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 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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.