Regulatory CSV Specialist: Validation & Compliance

OcyonBio, LLC; Aguadilla (PR); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

OcyonBio, LLC in Aguadilla, PR is seeking a CSV Specialist to develop, execute, and maintain computer system validation protocols to ensure regulatory compliance and data integrity across validated systems.

You will collaborate with QA, IT, and project management to support system implementations, perform risk assessments, and respond to regulatory inquiries in line with FDA 21 CFR Part 11 and GxP guidelines; strong communication and documentation skills are essential.

Formación

• Bachelor’s degree in Computer Science, IT, Life Sciences, or a related field.
• Proven experience in computer system validation within a regulated environment (pharma/biotech/medical devices).
• Strong understanding of FDA 21 CFR Part 11, GAMP 5, and related guidelines.
• Experience with validation documents (URS, IQ, OQ, PQ) and risk assessments.
• Excellent written and verbal communication skills.

Responsabilidades

• Develop, review, and execute validation plans, protocols, and reports per regulatory requirements.
• Coordinate with IT, QA, and business units to align validation with timelines and standards.
• Perform risk assessments and impact analyses to identify compliance issues.
• Maintain and update validation documentation with traceability throughout lifecycle.
• Support audits and inspections by preparing documentation and addressing inquiries.

Conocimientos

Regulatory compliance understanding

Documentation

Attention to detail

Educación

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

Herramientas

Veeva

MasterControl

Descripción del empleo

OcyonBio, LLC in Aguadilla, PR is seeking a CSV Specialist to develop, execute, and maintain computer system validation protocols to ensure regulatory compliance and data integrity across validated systems.

You will collaborate with QA, IT, and project management to support system implementations, perform risk assessments, and respond to regulatory inquiries in line with FDA 21 CFR Part 11 and GxP guidelines; strong communication and documentation skills are essential.