Minimum 50% onsite required. The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. 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. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations.
Required Competencies: Knowledge, Skills, and Abilities: Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. 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. An equivalent combination of education, experience and training may substitute.