Specialist I, QA Validation

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world.  Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary This role is responsible for supporting the validation effort and, where required leading projects to ensure that equipment, facilities, utilities, processes and computer systems utilized in the manufacture of product are validated for intended use. The role will also be responsible for providing leadership and technical guidance aimed at implementing best practices and improving the overall performance of the validation team and quality processes. Responsibilities Review, assess and approve (as applicable) CSV related materials for all local and global Computerized System projects Apply Global GxP requirements as part of a pragmatic validation strategy for computerized systems Establish and enhance the relationships between IT, validation, and business units, through collaboration, respectful challenge, and ability to strongly support QA decisions Continually monitor the effectiveness of the DI/CSV program, and recommend optimization opportunities as identified Participate, as needed, in audits of DI/computerized systems, both internal and external. Deliver CSV education and awareness, to enhance site level awareness of Data Integrity requirements, and associate accountabilities QA owner and SME for Data Integrity Assessments/Computer System Risk Assessments, Data Stream Mapping, Remediation Design, Report Creation. Participate in investigations and corrective actions of data related incidents and report open DI vulnerabilities to site leadership Responsible for process related activities including the development of validation strategies, the estimation of validation timelines and resource requirements, the generation and approval of the project validation plans, the development of robust and efficient validation test protocols and reports, for new and existing processes. Working with the cross functional teams in the development and execution of validation activities associated with new equipment, processes or system upgrades. Participating in project activities including design of systems and equipment to ensure that they comply with applicable regulations & International Standards. Providing technical input into all phases of the validation lifecycle, i.e. from design through to the commissioning and qualification execution phase and through to validation maintenance. Review and approval of documents prepared by the validation team, other departments and contractor organizations as required. Resolving and assisting in the closure of deviations initiated during validation activities or as related to critical process parameters. Assisting in the implementation…