Job Application

Validation Engineer

Company Overview

Valina Services is a Quality Assurance (QA) and Commissioning, Qualification, and Validation (CQV) solutions provider for the Life Science industry. We offer personalised and focused solutions for customers across the healthcare, pharmaceutical, and manufacturing domain.

Location

Singapore

Job Description

As a Validation Engineer, you will be working for our clients in the respect of the applicable regulations and quality procedures. The main responsibilities of the Engineer will be:

• To be responsible for preparing and/or executing validation activities and documentation for Computerized Systems, under respected regulations or guidelines: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5, Annex 11, etc.

• To create and modify validation documentation, including:

• User Requirements Specifications (URS)

• Criticality analysis and Risk Analysis

• Validation Plan and Report

• Protocols, Scripts and Reports for IQ, OQ, and PQ

• Reports which summarize the results of the test executions

• Execution of qualifications scripts and reporting Validation deviations

Job Requirements

• Degree (or similar) in IT, Engineering or Science

• 2 years experience working in GxP environment would be a plus, beginners are accepted and trained

• 2 years experience working on CSV projects would be appreciated, beginners are accepted and trained

• Excellent written/verbal English language skills are required. Other languages (French/German/Spanish) would be a plus

• Strong organizational and project management skills

• Familiar with GxP compliance requirements (FDA, EMA, GAMP 5, 21 CFR Part 11, PICs, etc.)

What We Offer

• Competitive basic salary and commission package

• Collaborative and team-oriented culture that embraces diversity

• Comprehensive medical and dental benefits

• Flexible hybrid work policy