Kerja Sepenuh Masa, System Qualification Engineer di Coalesce Management Consulting - Maukerja

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 protocols, and summary reports.
• Draft and support Data Integrity Risk Assessments for laboratory systems to ensure compliance with GMP and regulatory expectations.
• Prepare system decommissioning documents, including Decommissioning Plans and Decommissioning Summary Reports.
• Draft and maintain Operations and Maintenance SOPs for QC laboratory computerized systems and related equipment.
• Support the generation and implementation of Preventive Maintenance programs for laboratory systems.
• Coordinate with equipment vendors for vendor qualification, system setup, testing, documentation, and troubleshooting activities.
• Work closely with cross-functional stakeholders, including Facilities & Engineering, QA, QC, and IT, to ensure timely completion of qualification and validation deliverables.
• Ensure all qualification and validation activities are completed in accordance with GMP, company procedures, data integrity principles, and regulatory requirements.
• Support inspection readiness, audit preparation, and continuous improvement initiatives related to QC laboratory systems.

Requirements

• Diploma or Degree in Science, Engineering, Pharmaceutical Science, Biotechnology, Computer Science, or a related discipline.
• Prior experience in QC qualification, computer system validation, lab system validation, or analytical equipment qualification within a GMP-regulated environment.
• Familiarity with laboratory analytical systems such as Agilent, Empower, LIMS, ELN, UV-Vis, FTIR, or similar systems.
• Detail-oriented, organized, and able to manage multiple qualification activities within project timelines.