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