Senior Quality Engineer — CSV, Risk & Data Integrity

Johnson & Johnson Co.; Spring Valley Estates (GA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Engineer to lead computerized system validation strategies in a regulated environment. You will apply risk-based approaches to qualification, maintain data integrity, and collaborate with Quality, Manufacturing, IT, and Engineering to ensure system readiness and compliance.

Responsibilities include reviewing validation documentation, guiding change control, and supporting investigations of quality issues, ensuring systems remain validated and

Qualifications

• Analytical thinking to interpret complex data and regulatory requirements.
• Understand data-integrity concepts and electronic records controls.
• Assess risk and translate into validation/qualification activities.
• Lead or support computerized system validation and lifecycle activities.
• Collaborate across Quality, IT, Manufacturing, and Engineering teams.
• Communicate technical and regulatory concepts clearly to stakeholders.

Responsibilities

• Support qualification and validation activities for equipment and computerized systems used in regulated processes.
• Apply risk-based approaches to determine scope and rigor of qualification/validation.
• Review lifecycle documents: validation plans, URS, functional specs, risk assessments, test scripts/ Protocols.
• Provide change management guidance for validation strategies based on use and risk.
• Ensure validated systems remain controlled throughout their lifecycle; participate in risk assessments.
• Assist investigations of validation discrepancies and system quality issues.

Skills

Analytical Reasoning

Data Integrity

Risk Assessment

Validation/Qualification

Cross-functional Collaboration

Communication

Education

Bachelor’s degree in Engineering/CS/IS/Life Sciences

Job description

Johnson & Johnson is seeking a Senior Quality Engineer to lead computerized system validation strategies in a regulated environment. You will apply risk-based approaches to qualification, maintain data integrity, and collaborate with Quality, Manufacturing, IT, and Engineering to ensure system readiness and compliance.

Responsibilities include reviewing validation documentation, guiding change control, and supporting investigations of quality issues, ensuring systems remain validated and