System Qualification Engineer

We are looking for a Quality Control System 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 p...

Ready to Apply?

Submit your application today and join our talented team at Coalesce Management Consulting.