Posted 24 months ago

Validation Engineer

ChennaiOn-siteFull-time

AI Summary

Validation Engineer focusing on leading validation activities, risk-based validation strategies, and documentation for product releases in collaboration with Product, Engineering, and Testing teams.

About this role

Requirement:

Bachelor's degree in Engineering, Computer Science, or a related field.

5+ years of experience in software validation or a related field.

Strong knowledge of validation principles, methodologies, and regulations (GAMP, FDA, etc.).

Experience in performing risk assessments and generating risk-based validation strategies.

Experience in generating validation documentation, such as validation plans, protocols, and reports.

Knowledge of software development life cycle (SDLC) and software testing concepts.

Strong analytical and problem-solving skills.

Excellent written and verbal communication skills.

Ability to work independently and collaboratively in a fast-paced, dynamic environment.

Attention to detail and a commitment to delivering high-quality work.

Ability to mentor and lead small projects

Responsibilities:

Hands-on work in an individual capacity leading to deliverables

Diligently work with Product, Engineering, and Testing teams to gain an understanding of Product functions.

Review Product Requirements including Epics, User stories, User Requirements, Software Requirements, etc.

Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines

Create realistic test cases and test data based on customer usage scenarios.

Execute test cases, create defects, create deviations, and report test results.

Peer review Test cases, test data, and Test designs

Work in a highly collaborative team environment, with communication across many team members.

Good understanding of the company QMS standards

Author documents in accordance with the QMS guidelines

Ability to manage a team - Allocate work, review work and guide

Manage complete validation of products

Skills

Compliance/regulatory KnowledgeDefect TrackingDocumentation StandardsEPICs And User StoriesFDA ValidationGAMPIQ/OQ/PQ ProtocolsLeadership Of Small TeamsPeer ReviewQMS GuidelinesRequirements AnalysisRisk AssessmentSDLCSoftware TestingTest Case DesignValidation PlansValidation Reports

Validation Engineer

About this role

Requirement:

Responsibilities:

Skills

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