Laboratory & Validation Specialist

## Laboratory & Validation Specialist Apply locations:
Lincoln time type:
Full time posted on:
Posted Todayjob requisition :
JR
** Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals.
**** At Zoetis in Lincoln, NE we manufacture high quality medicines for companion animals and livestock. Our plant has been recognized as one of 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
** The Laboratory & Validation Specialist position develops, performs, and documents troubleshooting, calibration, preventive maintenance, and qualification activities on a diverse variety of new and existing bio-pharmaceutical equipment in support of Quality Operations testing laboratories and the site’s Manufacturing facilities. Work is scheduled and executed in a largely self-directed manner, while working closely with system owners to support Lincoln site engineering, manufacturing, and quality efforts.
*
* Hours:

1st shift, 7:30am – 4:00pm (typical)
**** Position Responsibilities
*** Performing qualification/revalidation activities on a wide variety of analytical/process equipment throughout the Lincoln site, utilizing specialized testing methodology, tools, and instrumentation. Specific focus will be on equipment and processes utilized in the Quality Control laboratories.
* Development of validation test protocols and proper documentation, evaluation of test results, and summarization of testing data.
* Assuring that equipment / processes that require qualification/revalidation are in compliance with current Zoetis SOP’s/standards, GMP & USP guidelines, and FDA, USDA, EU, and other regulatory agency requirements.
* Execution and/or technical review of laboratory equipment calibration/performance data.
* Coordinating work activities with relevant stakeholders to maintain required schedules.
* Scheduling and managing outside equipment vendor installation and testing activities.
* Assisting internal customers (including cost center owners and engineering project managers) with specification of new equipment.
* Troubleshooting and facilitating repair of existing laboratory/process equipment.
* 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, SAP, Empower, and other lab/production data acquisition systems for information input, review, and report generation.
** Education and Experience
*** Associate degree in engineering, Science or closely related field required. Bachelor’s degree preferred. Equivalent experience will be considered.
* 3-5 years of relevant bio-pharma process and validation experience.
* Two or more years in an analytical testing laboratory performing wet chemistry testing or instrumentation testing including HPLC, AA, GC, and UV/Vis preferred.
* Experience in qualification, calibration, and/or repair of analytical instruments.
* Experience with Empower data acquisition system preferred.
** Technical Skills and Competencies Required
*** Knowledge and experience in computerized laboratory systems, instrumentation, and equipment. Specific ability to operate and troubleshoot.
* Experience desired working with a variety of bio-pharmaceutical equipment/processes including autoclaves, fermenters, bioreactors, depyrogenation tunnels, coolers, freezers, incubators, SIP, CIP, and VHP.
* Experience in writing and executing validation protocols for cGMP and cGLP facilities and equipment.
* Demonstrated proficiency in set-up and use of equipment normally used in calibration and validation, including Kaye Validator and Valprobes.
* Demonstrated ability to plan and organize.
*…