Benchtop IT / CSV Engineer – QC Laboratory Systems

ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading technology solutions firm in Singapore is seeking a Benchtop IT / CSV Engineer to support validation and compliance activities for laboratory computerized systems. The role involves preparing validation deliverables, executing test scripts, and ensuring compliance with GxP and regulatory requirements. The ideal candidate has a Bachelor's degree and 3-6 years of experience in CSV, preferably in QC laboratories. Competitive salary and benefits included.

Qualifications

• 3–6 years of experience in Computer System Validation (CSV), preferably in QC/analytical laboratories.
• Hands-on experience in validation report preparation and QA review coordination.
• Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.

Responsibilities

• Support Computer System Validation (CSV) activities for QC lab systems.
• Develop and execute IQ, OQ, PQ protocols, test scripts, and validation reports.
• Collaborate with QA, IT, and Laboratory teams for system lifecycle maintenance.

Skills

Computer System Validation (CSV)

Test case drafting and execution

GxP Compliance

Collaboration with teams

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline

Tools

Empower

LabX

Chromeleon

LabSolutions

Job description

Job Title and Industry

Job Title: Benchtop IT / CSV Engineer – QC Laboratory Systems
Industry: Life Sciences / Pharmaceutical Manufacturing

Role Overview

We are seeking a Benchtop IT / CSV Engineer to support validation and compliance activities for laboratory computerized systems and instruments used in QC and analytical environments. The role involves preparing validation deliverables, executing test scripts, and ensuring that all benchtop and laboratory systems meet GxP, Data Integrity, and 21 CFR Part 11 requirements.

Key Responsibilities

• Support Computer System Validation (CSV) activities for QC lab systems, including benchtop instruments and associated software (e.g., Empower, LabX, Chromeleon, LabSolutions, etc.).
• Develop and execute IQ, OQ, PQ protocols, test scripts, and validation reports in line with site and corporate procedures.
• Prepare and maintain validation documentation — URS, Risk Assessments, Traceability Matrix, Summary Reports, and Validation Plan.
• Provide technical and validation support for instrument installation, configuration, and qualification.
• Ensure all systems and documentation comply with GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity (ALCOA+) standards.
• Collaborate with QA, IT, and Laboratory teams for change control, deviation management, and system lifecycle maintenance.
• Participate in system reviews, backup and restore verification, and access control management for validated systems.
• Maintain audit-ready documentation and support internal or regulatory inspections.

Qualifications & Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 3–6 years of experience in Computer System Validation (CSV), preferably supporting QC / analytical laboratories.
• Hands‑on experience in test case drafting and execution, validation report preparation, and QA review coordination.
• Exposure to benchtop instrument qualification and validation (HPLC, GC, TOC, Balances, etc.) and related software.
• Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
• Ability to work independently and collaboratively with cross‑functional teams.