Validation Engineer

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