Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles Understanding the concept of Critical thinking for Computerized Systems Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs) Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods With advanced technical document writing and time management skills, including ability to prioritize and manage expectations Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties Education and Experience: Bachelor's degree in a life sciences, engineering or technology discipline required Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipe validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.