Position Overview The QA Engineer, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Engineer, DSM ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Job Description What You’ll Do Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility Ensures project and operational quality objectives are met within desired timelines Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections. Performs other duties as assigned.