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Junior Computer System Validation (CSV) Engineer – Automation/Lab systems
Process Engineering Specialists
Validate lab equipment CSV ensuring GxP compliance and data integrity.
10d ago
Intermediate (4-7 years), Experienced (8-12 years), Junior (1-3 years)
Full Time
Singapore, Singapore
Onsite
Company Size
150 Employees
Service Specialisms
Project Management
Construction Management
Commissioning & Qualification
Automation
Outsourced Personnel
Sector Specialisms
Biotechnology
Pharmaceutical
Medical Technologies
Nutritional
Food
Role
What you would be doing
impact assessment
risk evaluation
regulatory compliance
csv activities
validation docs
lifecycle management
- Perform system impact assessments and risk evaluations to determine validation requirements.
- Ensure 21 CFR Part 11 and Data Integrity (DI) compliance for laboratory systems.
- Lead and execute CSV activities for Lab Equipment ensuring compliance with regulatory and company requirements.
- Investigate and resolve validation deviations, issues, and non-conformances related to laboratory equipment.
- Develop and maintain validation documentation, including User Requirement Specifications (URS), Validation Plans (VP), Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports (VSR).
- Participate in software/system lifecycle activities, including system design, testing, implementation, and periodic reviews.
What you bring
csv
gxp
1 year
pharma
biotech
quality
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.
- Minimum 1 years of experience in CSV within a GxP-regulated industry (pharmaceutical, biotech, or medical devices).
Information not given or found
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Interview process
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Company
Overview
Founded 2012
Year Established
The company was established with a vision to provide specialized engineering support to life-sciences projects.
Revenue SGD 10M
Annual Revenue
Generating over SGD 10 million annually, the company has shown consistent growth and success.
85% Repeat Rate
Client Retention Rate
With an impressive 85% repeat business rate, the company is known for its high-quality and reliable services.
- Delivers high-value, repeatable outcomes for multinational clients across various industries.
- Provides comprehensive support from initial design through commissioning, including automation and validation services.
- Specializes in handling complex projects in pharmaceutical, nutritional, and biotech facilities.
- Manages CAPEX builds, validates GMP production lines, and integrates advanced control systems.
- Ensures seamless coordination across continents and stakeholders with a globally distributed team.
- Maintains a global presence with offices in key locations, ensuring strong local execution capabilities.
- Customer satisfaction is a top priority.
- Delivering practical, value-driven solutions is at the core of what we do.
- Safety and quality are prioritized in every project.
- Collaboration and teamwork are essential for achieving the best outcomes.
- Innovation is central to how we approach problem-solving.
- Maintaining high ethical standards is fundamental to our operations.
2050
Carbon Emissions Target
Aiming to achieve net-zero carbon emissions by 2050 as part of their commitment to climate action.
- Solutions prioritize energy efficiency and environmental impact reduction.
- Promotes sustainability throughout the project lifecycle, from design to execution.
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