Junior Computer System Validation (CSV) Engineer – Automation/Lab systems

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

Job summary

A leading engineering services company in Singapore is seeking a Computer System Validation Engineer. This role requires at least 2 years of experience in the GxP-regulated industry, focusing on ensuring compliance with regulatory standards. The position involves executing CSV activities for Lab Equipment, developing validation documentation, and supporting system lifecycle activities. Candidates should demonstrate strong skills in risk assessments and data integrity compliance.

Qualifications

• Minimum 2 years of experience in CSV within a GxP-regulated industry.
• Lead and execute CSV activities for Lab Equipment.
• Develop and maintain validation documentation.

Responsibilities

• Perform system impact assessments to determine validation requirements.
• Ensure 21 CFR Part 11 compliance for laboratory systems.
• Investigate and resolve validation deviations.

Skills

Computer System Validation (CSV)

Experience in GxP-regulated industry

Risk Assessments

Data Integrity compliance

Job description

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

This focus, and our people\'s experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

Overview

We are currently looking for Computer System Validation (CSV) engineer to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities

• Minimum 2 years of experience in CSV within a GxP-regulated industry (pharmaceutical, biotech, or medical devices).
• Lead and execute CSV activities for Lab Equipment ensuring compliance with regulatory and company requirements.
• Develop and maintain validation documentation, including User Requirement Specifications (URS), Validation Plans (VP), Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports (VSR).
• Perform system impact assessments and risk evaluations to determine validation requirements.
• Ensure 21 CFR Part 11 and Data Integrity (DI) compliance for laboratory systems.
• Participate in software/system lifecycle activities, including system design, testing, implementation, and periodic reviews.
• Investigate and resolve validation deviations, issues, and non-conformances related to laboratory equipment.

If you\'d like to find out about this opportunity, please forward your CV to Nelson Anthony ([e-mail]).

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PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.