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Validation Engineer

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.


 


Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.


position supports the manufacturing facility through the qualification and/or validation of cleaning processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. 


The incumbent is required to assist in the creation of cleaning validation protocols, coordinate and execute test activities necessary for validation, and summarize results. In addition, the incumbent may also direct or participate in performing technical failure analysis on processes not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce process variability, and apply statistical analysis to process development activities.


Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May exercise judgment in developing these methods. May determine methods and procedures on new assignments.


Minimum BA or BS degree preferably in engineering or science field. Minimum 1+ years validation experience.




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