CSV Validation Specialist - Regulated Systems & Compliance

Automatic Data Processing, Inc.; Aguadilla (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Automatic Data Processing, Inc. is seeking a CSV Specialist in Aguadilla, PR to develop, execute, and maintain computer system validation protocols ensuring regulatory compliance and data integrity.

You will collaborate with QA, IT, and project teams to support system implementations, manage risk assessments, and maintain traceability across the validation lifecycle in a controlled environment.

Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
• Experience in computer system validation within a regulated environment, preferably in pharmaceutical, biotech, or medical device industries.
• Strong understanding of regulatory requirements including FDA 21 CFR Part 11, GAMP 5, and other relevant guidelines.
• Experience with validation documentation such as URS, IQ, OQ, PQ, and risk assessments.
• Excellent written and verbal communication skills to effectively document and present validation activities.

Responsibilities

• Develop, review, and execute validation plans, protocols, and reports for computer systems in accordance with regulatory requirements such as FDA 21 CFR Part 11 and GxP guidelines.
• Coordinate and collaborate with IT, quality assurance, and business units to ensure validation activities align with project timelines and compliance standards.
• Perform risk assessments and impact analyses to identify potential compliance issues and recommend mitigation strategies.
• Maintain and update validation documentation and ensure traceability throughout the system lifecycle.
• Support audits and inspections by preparing necessary documentation and responding to regulatory inquiries related to computer system validation.

Skills

Analytical skills

Regulatory compliance knowledge

Documentation

Validation

Communication

Education

Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field

Tools

Veeva

MasterControl

Job description

Automatic Data Processing, Inc. is seeking a CSV Specialist in Aguadilla, PR to develop, execute, and maintain computer system validation protocols ensuring regulatory compliance and data integrity.

You will collaborate with QA, IT, and project teams to support system implementations, manage risk assessments, and maintain traceability across the validation lifecycle in a controlled environment.