Senior Computer System Validation (CSV)

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Senior Computer System Validation (CSV)

POSITION PURPOSE:

We are seeking a Senior Computer System Validation (CSV) Engineer to lead and manage validation activities for local R&D business software applications used in a regulated medical device software development environment. This role is responsible for ensuring GxP and non- GxP systems comply with regulatory requirements data integrity and security principles and internal quality standards across the full system lifecycle.

This role works closely with global cross functional teams to support compliant implementations documentation effective lifecycle management and audit readiness. The ideal candidate will be a proactive leader who can drive outcomes and align with Bayers mission and values.

YOUR TASKS AND RESPONSIBILITIES:

• Lead and perform computer system validation activities for regulated R&D software tools including Atlassian suite (JIRA Confluence Crowd) IBM ELM Suite (RQM DNG) Jama GitHub and JFrog Artifactory.
• Develop execute and maintain validation deliverables such as user requirement specs validation plans test protocols test scripts test reports risk assessments and change documentation.
• Execute formal validation testing activities (UAT IQ OQ PQ) for GxP relevant systems.
• Draft review and update SOPs and procedural documentation in compliance with GxP requirements and internal quality processes.
• Apply risk based validation approaches to ensure efficient compliant validation activities.
• Support system lifecycle management change control and impact assessments for validated systems.
• Ensure compliance with 21 CFR Part 11 GxP regulation and data integrity expectations.
• Support and coordinate user access management and administrative activities for validated tools.
• Manage tool related service (new requests project efforts and break-fix) and administration requests via ServiceNow.
• Collaborate closely with Software Quality Management IT Engineering and other stakeholders to ensure audit readiness.
• Support internal and external audits access reviews and inspections by providing validation evidence and subject matter expertise.
• Participate in deviation management CAPA activities and continuous improvement initiatives related to validated systems.

WHO YOU ARE:

• 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.

Preferred

• Familiarity with tools such as IBMs Engineering Lifecycle Management Atlassians 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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