Validation Engineer

Team: Validation

Location: Chennai

Commitment: Full-Time

Workplace Type: onsite

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