QC Systems Engineer (Lab Equipment CSV)

Advanced Manufacturing Tech Solutions (AMTSOL) - www.amtsol.com A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business. Role: System Owner Delegate QC Systems (Lab Equipment CSV) Location : Singapore The role will act as a key liaison between QC, IT, Automation, and Validation teams, ensuring laboratory computerized systems remain compliant, validated, and inspection-ready in accordance with global regulatory requirements Key Responsibilities Act as System Owner Delegate for QC laboratory computerized systems and analytical equipment. Ensure systems remain compliant with GxP, 21 CFR Part 11, EU Annex 11, and Data Integrity requirements . Support CSV lifecycle activities including URS, risk assessments, validation planning, IQ/OQ/PQ oversight, and change control. Review and approve validation documentation in alignment with corporate and regulatory standards. Manage system updates, patches, configuration changes, and periodic reviews. Support deviation investigations, CAPAs, and audit/inspection readiness activities. Coordinate with vendors, IT teams, and cross-functional stakeholders for system enhancements and troubleshooting. Ensure backup, disaster recovery, access management, and data integrity controls are maintained. Required Experience & Skills 5+ years of experience in Pharmaceutical / Life Sciences Manufacturing environment. Strong hands-on experience in Computerized System Validation (CSV) for laboratory systems. Experience supporting QC Lab systems such as: LIMS CDS (e.g., Empower, OpenLab) ELN Analytical instruments and standalone lab equipment systems Good understanding of: GAMP 5 guidelines Data Integrity principles Change Management & Risk Management Experience supporting regulatory audits (FDA, EMA, MHRA, etc.). Strong documentation, stakeholder management, and problem-solving skills