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Urgent! Benchtop IT / CSV Engineer - QC Laboratory Systems Job Opening In Singapore, Singapore – Now Hiring ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD.

Benchtop IT / CSV Engineer QC Laboratory Systems



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.


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Required Skill Profession

Other General



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