Senior Computer System Validation (CSV)

Bachelor of Engineering (BE), Bachelor of Technology (BTech), Bachelor of Science (BSc), or equivalent degree in Computer Science, Information Technology, Electronics, Biomedical Engineering, or a related technical discipline.

Greater than 5 years’ experience with computer software validation in a regulated environment.

Strong understanding and prior experience with Computer System Validation (CSV) and CSA risk based validation methodologies.

Strong experience working with GxP regulated systems in pharmaceutical, medical device, or similarly regulated industries.

Working knowledge of data integrity principles.

Hands on experience authoring and maintaining validation documentation, including:

User Requirements Specifications, Configuration Specifications, Test Scripts

UAT, IQ, OQ, PQ

Test protocols and reports

Change records and risk documentation

Knowledge of application change control, deviation handling, and CAPA processes.

Ability to collaborate and communication effectively with global, cross functional teams.

Accountable, willing to go the extra mile style of working.

Familiarity with tools such as IBM’s Engineering Lifecycle Management, Atlassian’s suite (JIRA, Confluence), GitHub, and JFrog Software Supply Chain, at an administrator level.

Prior experience with internal or external audits and inspections.

Prior experience supporting regulated R&D software environments.

Previous Scrum Master experience utilizing Jira is a plus

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