Laboratory & Validation Specialist

Zoetis•Lincoln, NE

2d•Onsite

About The Position

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. 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.

Requirements

Associate degree in engineering, Science or closely related field required.
Equivalent experience will be considered.
3-5 years of relevant bio-pharma process and validation experience.
Experience in qualification, calibration, and/or repair of analytical instruments.
Knowledge and experience in computerized laboratory systems, instrumentation, and equipment.
Specific ability to operate and troubleshoot.
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.
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, cGLPs, and USDA regulations.
SAFELY work in an industrial environment.
Physical conditions include lifting, sitting, standing, and walking.
Primary and secondary gowning changes required.
All applicants must possess or obtain authorization to work in the US for Zoetis.

Nice To Haves

Bachelor’s degree preferred.
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 with Empower data acquisition system preferred.
Experience desired working with a variety of bio-pharmaceutical equipment/processes including autoclaves, fermenters, bioreactors, depyrogenation tunnels, coolers, freezers, incubators, SIP, CIP, and VHP.

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.