Computer System Validation Engineer (Senior)

Integrix Solutions • Biotechnology • Science & Engineering • 28 days ago

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Salary

$66k – $84k per year (gross)

Location

In office (Singapore)

Seniority

Senior · 3+ years exp

Employment

Full-Time

First seen by Alion on Sep 14, 2026.

Overview

Company

Impact

Profile match

Integrix Solutions

Integrix Solutions provides expert automation engineering services for process industries, delivering quality, compliance, and reliable project execution.

integrixsolutions.com • Singapore • UTC+08:00 • Manufacturing & Industrial Software • Industrial Automation • Est. 2006

Job Description:

Create, review or approve validation deliverables for GMP computerized systems including but not limited to:

- User Requirements Specifications

- Design Reviews

- Criticality assessments

- Validation protocols (IQ, OQ, PQ)

- Incident/deviation reports related to test protocol execution

Provide validation guidance to cross-functional teams based on customers' Standard Operating Procedures (SOPs)
Provide QA oversight and review during different phases of the automation & ITOT projects in the pharmaceutical manufacturing industry
Validation of Process Control Systems and PLC system

Requirements:

Degree in Engineering or Science, preferably in Chemical/Biochemical Engineering, Electrical Engineering or Computer Science/IT.
Minimum 3 years of computer system validation or automation experience in Pharmaceutical manufacturing Industry
Customer-focused and uphold high work quality standards
Excellent communication skills - ability to communicate and collaborate effectively with various stakeholders
Previous Emerson DeltaV, ITOT infrastructure, PLC experience is preferred
Experienced in developing and reviewing automation validation deliverables
Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines

Skills

GxP, Emerson DeltaV, CGMP practices, GMP, GAMP, System Testing, Computer Vision, PLC, Computerised Systems Validation, Protocol, Technical Validation, Manufacturing, Electrical Engineering

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