Validation Services Specialist

1 week ago

Lincoln, Lincolnshire, United Kingdom Zoetis Full time

About Zoetis

Zoetis is a leading manufacturer and supplier of animal pharmaceuticals, committed to delivering high-quality medicines for dogs, cats, and livestock.

Job Summary

The Validation Services Specialist will be responsible for planning, developing, and performing validation and revalidation testing on various bio-pharmaceutical equipment and facilities. This role will work closely with system owners to support the Lincoln site's engineering, manufacturing, and quality efforts.

Key Responsibilities

  • Perform verification/validation/revalidation activities on equipment throughout the Lincoln site, utilizing specialized testing tools and instrumentation.
  • Develop test protocols and proper documentation, evaluate test results, and summarize testing data.
  • Ensure equipment/processes requiring revalidation comply with current SOPs, GMP guidelines, and FDA, USDA, EU, and internal Zoetis standards.
  • Coordinate work activities with stakeholders to maintain required schedules.
  • Assist customers with specification of new equipment and troubleshooting of existing equipment that require validation/revalidation.
  • Develop documentation, execute testing, and contribute to equipment change controls and/or site investigational efforts.
  • Participate in Engineering activities and training, utilizing necessary systems to complete assigned tasks.
  • Interface with the Valgenesis qualification program, Trackwise, and SAP for data input and report generation.

Requirements

  • Associate degree in Engineering, Science, or a closely related field required; Bachelor's degree preferred.
  • 3-5 years of relevant bio-pharma process and validation experience.

Technical Skills and Competencies

  • Demonstrated proficiency in set-up and use of equipment normally used in calibration and validation, including Kaye Validator and Valprobes.
  • Experience working with various 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 multiple tasks and bring them to completion on schedule.
  • Demonstrated ability to interact with all levels of the department, other departments, consultants, contractors, and suppliers.
  • Established knowledge of cGMPs, EU, and USDA regulations.

Physical Position Requirements

  • Work safely 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.

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