Validation Services Specialist

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in Colorado. Base pay may vary based on location and other factors.

Base Pay Range: $XX - $XX

[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.]

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation, and disability insurance.

JOB DESCRIPTION:

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 Lincoln and we continue to grow.

Benefits Include:

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays

401(k) match with company profit sharing

Tuition reimbursement

Student Loan Repayment Assistance

Position Summary

The Validation Services Specialist position is responsible for planning, developing, and performing validation and revalidation testing on a diverse variety of new and existing bio-pharmaceutical equipment and facilities. Work is scheduled and executed in a largely self-directed manner, while working closely with system owners to support the Lincoln site engineering, manufacturing, and quality efforts.

Position Responsibilities

• Primary responsibility will be performing verification/validation/revalidation activities on a wide variety of equipment throughout the Lincoln site, utilizing specialized testing tools and instrumentation.
• Development of test protocols and proper documentation, evaluation of test results, and summarization of testing data.
• Assuring that equipment / processes that require re-validation are in compliance with current SOP’s, GMP guidelines, and FDA, USDA, EU, and internal Zoetis standards.
• Coordinating work activities with relevant stakeholders to maintain required schedules.
• Assisting customers (including cost center owners and engineering project managers) with specification of new equipment and troubleshooting of existing equipment that require validation/re-validation.
• Developing documentation, executing testing, and otherwise contributing as necessary to equipment change controls and/or site investigational efforts.
• Participate in all relevant Engineering activities and training, and utilize all systems necessary to complete assigned tasks.

• Interface with the Valgenesis qualification program, Trackwise, and SAP for data input and report generation.

Organizational Relationships

Reports to the Manager of Engineering Systems as a part of Lincoln’s Engineering, Maintenance, and Utilities division. Works with internal team members as well as cross-functional teams throughout the site.

Education and Experience

• Associate’s Degree in Engineering, Science or closely related field required. Bachelor’s preferred. Equivalent experience will be considered.
• 3-5 years of relevant bio-pharma process and validation experience.

Technical Skills and Competencies Required

• Demonstrated proficiency in set-up and use of equipment normally used in calibration and validation, including Kaye Validator and Valprobes.
• Experience working with a variety of bio-pharmaceutical equipment/processes including autoclaves, fermenters, bioreactors, depyrogentation tunnels, coolers, freezers, incubators, SIP, CIP, and VHP.
• Experience in writing and executing validation protocols for cGMP facilities.
• Demonstrated ability to plan and organize.
• Demonstrated ability to independently manage a variety of tasks at one time and bring them

to completion on schedule.

• Demonstrated ability to interact with all levels of the department, all levels of other

departments, consultants, contractors, and suppliers.

• Established knowledge of cGMPs and USDA regulations.

Physical Position Requirements

• SAFELY work in an industrial environment.
• Physical conditions include lifting, sitting, standing, and walking.
• Primary and secondary gowning changes required.
• Occasional weekend/off-shift work as needed.