QC - Validation Engineer

ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading manufacturing solutions provider in Singapore is seeking a QC Engineer to validate analytical laboratory instruments in a GMP-regulated environment. You will focus on ensuring compliance with regulatory standards and contribute to continuous improvement initiatives within the QC lab. The ideal candidate will have 5-10 years of experience in CSV and validation processes, along with a strong understanding of good manufacturing practices.

Qualifications

• 5–10 years’ experience in CSV/validation of analytical instruments within QC labs in pharmaceutical/biotech.
• Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity frameworks.
• Hands-on use of Kneat or other e-validation platforms preferred.

Responsibilities

• Plan, execute, and document qualification/validation of analytical instruments.
• Prepare, review, and execute CSV deliverables such as URS, IQ/OQ/PQ.
• Perform data integrity assessments and ensure compliance with ALCOA+, GDP, and cGMP guidelines.
• Draft, review, and maintain validation-related SOPs for QC systems.
• Support audits and inspections with accurate validation documentation.
• Contribute to continuous improvement initiatives to strengthen QC lab compliance.

Skills

CSV/validation of analytical instruments

Technical documentation

Troubleshooting skills

Cross-functional collaboration

Experience with microbiology analytical equipment

Education

Bachelor’s degree in Chemistry, Life Sciences, Engineering, or related field

Tools

Kneat

HPLC

GC

UV

LIMS

Empower

Job description

We are looking for a QC Engineer to support validation of analytical laboratory instruments and computerized systems in a GMP-regulated environment. The role focuses on ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.

Key Responsibilities

• Plan, execute, and document qualification/validation of analytical instruments (e.g., HPLC, GC, UV, CDS, LIMS, Empower).
• Prepare, review, and execute CSV deliverables such as URS, IQ/OQ/PQ, RTM, and summary reports.
• Perform data integrity assessments and ensure compliance with ALCOA+, GDP, and cGMP guidelines.
• Draft, review, and maintain validation-related SOPs for QC systems and equipment.
• Support audits and inspections with accurate validation documentation.
• Collaborate with QC, QA, and IT to ensure readiness for system lifecycle activities (periodic review, change control, upgrades, cyber-resilience).
• Contribute to continuous improvement initiatives to strengthen QC lab compliance.

Requirements

• Bachelor’s degree or higher in Chemistry, Life Sciences, Engineering, or related field.
• 5–10 years’ experience in CSV/validation of analytical instruments within QC labs in pharmaceutical/biotech.
• Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity frameworks.
• Experience with microbiology analytical equipment is an advantage.
• Hands-on use of Kneat or other e-validation platforms preferred.
• Strong technical documentation and troubleshooting skills.
• Able to work cross-functionally and support audit readiness.