Process Engineer (CQV) -Contract Position

MATRIX PROCESS AUTOMATION PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A technology solutions company in Singapore seeks a professional to support Computer System Validation for QC lab systems. The role involves developing and executing validation protocols while ensuring compliance with industry standards such as GAMP 5. The ideal candidate has a Bachelor's degree and 3–6 years of relevant experience, including hands-on validation documentation and benchtop instrument qualification.

Qualifications

• Bachelor’s degree in relevant field required.
• 3–6 years of experience in CSV is essential.
• Hands-on experience with test case drafting and validation is needed.

Responsibilities

• Develop and execute IQ, OQ, PQ protocols, test scripts, and validation reports.
• Prepare and maintain validation documentation.
• Ensure compliance with GAMP 5 and regulatory standards.

Skills

Computer System Validation (CSV)

Benchtop Instrument Qualification

Technical Support

GAMP 5 Compliance

Documentation Management

Education

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

Tools

Empower

LabX

Chromeleon

LabSolutions

Job description

Overview

Support Computer System Validation (CSV) activities for QC lab systems, including benchtop instruments and associated software (e.g., Empower, LabX, Chromeleon, LabSolutions, etc.).

Responsibilities

• 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), Benchtop IT, 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.

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