Quality Validation/Digital Specialist

Zoetis is the world's 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 Nebraska's 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:

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

Support the validation efforts at the Lincoln site. Work with teams to create validation documentation and assist in managing the validation efforts. Work with stake holders to implement a periodic review program of critical elements of the Lincoln validation program. Work with project teams to validate project work in accordance with procedures. Write validation documentation as required by the project.

Hours: 1st shift. Evening and weekend work may be required.

Position Responsibilities

• Provide Validation support for projects. This would include new products/processes and changes to existing process.
• Work with teams to ensure that validation procedures are followed.
• Conduct periodic reviews of equipment and processes including digital systems.
• Work with stakeholders to write validation project plans and summaries.
• Work with Cleaning, computer systems, method, process, and equipment validation to bring all pieces together in a validation project.
• Ensure that validation activities follow a stage gate process.
• Assist in defining the Validation program in Lincoln.
• Assist in writing validation documentation, User Requirements, Design review Documents, process validation protocols.

Education and Experience

• M S. with five years, B. S.\Engineering Deg or Quality Engineering Deg. with 7 years or equivalent in biological or pharmaceutical industry or engineering related discipline.
• A minimum of three years' experience with engineering, quality, or validation activities.

Technical Skills and Competencies Requirement

Minimum Qualifications:

• Experience in validation of processes, analytical methods, equipment, cleaning, software, computer systems, etc.
• Demonstrated knowledge of the Deviation Investigation, Change Control, Engineering and Manufacturing systems.
• Experience in Quality or system Oversight in a GMP environment.
• Familiarity with US. Regulations (USDA) for biological products, FDA regulations for pharma/mAb products, and EU regulations and their application.

Preferred Qualifications:

• Strong written and oral communication and ability to effectively influence a team of professionals.
• Ability to establish appropriate timelines to meet project milestones and hold colleagues accountable to timelines and activities.
• Overall project management skills
• Process and detail oriented with the ability to review and/or prepare detailed structured documents.
• Demonstrated ability leading a complex team and influencing colleagues with no direct report relationship.
• Demonstrated ability to perform and reach targeted conclusions.
• Produce technical documents to include validation project plans and summaries.

Physical Position Requirements

• This position requires sitting, standing, and walking with occasional overtime/weekend work.
• Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.

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.