Validation Engineer

Jobtailor; Chennai District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Jobtailor in Chennai region is seeking a seasoned software testing/validation specialist to work in a regulated life sciences setting. You will design and run test plans, maintain system validation, and oversee documentation from scripts to validation summaries.

The role requires collaboration across teams, handling defects, and ensuring compliance with strict regulatory standards. The ideal candidate has 5–10 years in regulated software testing, strong SDLC knowledge, and hands-on experience

Qualifications

• Minimum 5 to 10 years of experience in software testing/validation in a regulated environment.
• Ability to manage multiple tasks and timelines.
• Ability to liaise with project teams on-site and remotely.
• Ability to bring/maintain systems to a validated state.
• In-depth knowledge of Software Development Life Cycle and major phases.
• Experience with testing/validation deliverables (Test/Validation Plan, Test Script, Validation Summary Report).
• Experience with various testing types (Black Box, GUI, System, PQ, UAT, Functional, Regression).
• Experience with applications in Java, .Net, Oracle, MySQL, C++ preferred; Katelon automation required.
• Strong knowledge of regulatory guidelines (21 CFR Part 11, Annex 11, GAMP 5).
• SQL and DB concepts preferred.
• Experience with Test Automation Tools or ALM is preferred.
• Strong problem solving and organizational skills.
• Strong verbal and written communication skills.

Responsibilities

• Engage in software testing and validation activities in a regulated life sciences environment.
• Collaborate with project teams to maintain system validation.
• Develop and execute test plans and validation protocols.
• Produce and review test documentation such as Test Scripts and Validation Summary Reports.
• Ensure compliance with regulatory standards.
• Manage defect tracking and resolution processes.

Skills

Software testing

Validation in regulated env

Test documentation

Defect management

Automation testing (Katalon)

Regulatory guidelines (21 CFR Part 11)

SQL basics

Communication skills

Tools

Katalon Studio

ALM tools

SQL

Job description

Responsibilities

• Engage in software testing and validation activities in a regulated life sciences environment
• Collaborate with project teams to maintain system validation
• Develop and execute test plans and validation protocols
• Produce and review test documentation such as Test Scripts and Validation Summary Reports
• Ensure compliance with regulatory standards
• Manage defect tracking and resolution processes

Requirements

• Minimum 5 to 10 years of experience in software testing/validation in a regulated environment
• Ability to successfully manage multiple tasks and timelines
• Ability to effectively liaise with project team members and other teams/departments, on-site and remotely
• Ability to perform and coordinate activities required to bring/maintain systems to a validated state
• In depth knowledge of Software Development Life Cycle and its major phases
• Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability matrix, Validation Summary Report is required
• Proven experience in different types of testing (including but not limited to Black Box Testing, Graphical User Interface (GUI) Testing, System Testing (OQ), User Acceptance Testing (PQ), Functional Testing, Regression Testing, etc.)
• Proven experience in testing applications developed in different programming languages and tools (i.e. Java, .Net, Oracle, MySQL, C++) is preferred
• Proven experience with automated testing, preferably the Katelon tool, required
• Strong knowledge of regulatory guidelines on computerized systems, 21 CFR Part 11, Annex 11, and/or GAMP 5
• Understanding of SQL and database concepts is preferred
• Experience in Test Automation Tools or Application Lifecycle Management is preferred
• Strong organizational and problem solving skills for tasks and functions related to testing and validation of applications
• Strong verbal and written communication skills