Job Description
We are looking for a QC Qualification Engineer to support the qualification, validation, maintenance, and lifecycle management of laboratory analytical computerized systems within a GMP-regulated environment. This role will work closely with QC, QA, IT, Facilities & Engineering, and external vendors to ensure laboratory systems are qualified, compliant, and maintained in accordance with regulatory and data integrity expectations. Key Responsibilities Support the initiation, execution, and end-to-end ownership of change controls related to laboratory analytical computerized system qualification. Manage qualification activities for standalone and laboratory systems such as Agilent systems, LIMS, Empower, ELN, UV-Vis, FTIR, and other QC analytical computerized systems. Draft and execute validation-related documents, including Validation Plans, User/Functional Requirements, IQ/OQ/PQ test scripts, validation protocols, and summary reports. Draft and support Data Integrity Risk Assessments f...