Cleaning Validation Analyst

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:

$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 Cleaning Validation Analyst is responsible for sampling and testing activities that support the cleaning validation program for the pharmaceutical and biological operational areas at the Lincoln manufacturing site. Primary responsibilities include the physical collection of samples from manufacturing equipment and analytical chemistry testing utilizing High Performance Liquid Chromatography (HPLC), Atomic Absorption Spectrometry (AAS), UV/Vis, and Total Organic Carbon (TOC) instrumentation. Additional responsibilities include writing task reports, developing protocols, and assisting with other administrative and documentation activities such as database entry, SOP updates, and investigation reports.

Hours: 1st shift. Overtime and weekends may be required.

Position Responsibilities

• Obtain samples from manufacturing equipment as outlined in Cleaning Validation protocols.
• Preparation and analysis of samples using HPLC, AA, UV/Vis, and TOC according to Standard Test Procedures
• Documentation of laboratory results and data review utilizing Good Laboratory Practices (GLP)
• Maintain cGMP compliance with department Standard Operating Procedures (SOPs), Zoetis Quality Standards, and 21CFR, EU and other regulatory guidelines.
• Assist with the development of cleaning validation protocols and write validation task reports.
• Assist with scheduling and other administration duties such as database maintenance, SOP updates, and investigation reports.
• Assist with analytical method validation.

Education and Experience

Minimum Qualifications: 2 or 4-year degree/certificate in a science-based field with analytical laboratory experience.

Preferred Qualifications: Bachelor's degree in chemistry or related field with knowledge or direct experience using HPLC, AA, TOC, and UV/Vis instrumentation.

Technical Skills and Competencies Required

Minimum Technical Skills/Competencies:

• Physical ability to collect samples from manufacturing equipment.
• Ability to perform analytical chemistry assays following Standard Test Procedures
• Familiarity of cGMPs and cGLPs
• Verbal and written communication skills (fluent in English)
• Knowledge of Microsoft Word and Excel
• Organizational skills
• Attention to detail.

Preferred Technical Skills/Competencies:

• Prior analytical laboratory experience with proficiency using HPLC, AA, TOC, and UV/Vis instrumentation.
• Experience with Waters Empower Chromatography Data System
• Functional knowledge of FDA/EU guidelines as they relate to cleaning validation.
• Technical writing skills
• Ability to establish appropriate timelines to meet key milestones with minimal supervision.
• Ability to work effectively in a team-based environment.

Physical Position Requirements

• This position requires general mobility when collecting samples which may include reaching overhead, squatting, and occasional use of a step ladder.
• Ability to lift materials up to 15 lbs.
• Occasional off-shift and weekend hours

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.