QC - Validation Engineer

3 days ago

Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

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.
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