Laboratory & Validation Specialist

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.
• 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.
• Coeordinating 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.

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.
• 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.

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.