CSV Specialist: Regulatory Validation & Compliance

Biosimilar Sciences PR LLC; Aguadilla (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Biosimilar Sciences PR LLC is seeking a CSV Specialist in Aguadilla, PR. You will develop, execute, and maintain computer system validation protocols to ensure data integrity and regulatory compliance across pharmaceutical and biotech systems.

You will work with QA, IT, and project management to assess risks, document validation activities, and support audits. The role requires attention to detail, strong communication, and familiarity with 21 CFR Part 11, GAMP 5, URS/IQ/OQ/PQ, and modern

Qualifications

• Bachelor’s degree in a related field.
• Experience with computer system validation in regulated industries.
• Knowledge of FDA 21 CFR Part 11 and GAMP 5.
• Experience with URS, IQ, OQ, PQ, and risk assessments.

Responsibilities

• Develop, review, and execute validation plans, protocols and reports.
• Ensure compliance with regulatory standards and GxP.
• Collaborate with QA, IT, and project management.
• Maintain traceability of validation artifacts throughout lifecycle.
• Support audits and regulatory inquiries.

Skills

Regulatory knowledge

Validation planning

Documentation

Communication

Education

Bachelor's degree in Computer Science/IT/Life Sciences

Tools

Veeva

MasterControl

Job description

Biosimilar Sciences PR LLC is seeking a CSV Specialist in Aguadilla, PR. You will develop, execute, and maintain computer system validation protocols to ensure data integrity and regulatory compliance across pharmaceutical and biotech systems.

You will work with QA, IT, and project management to assess risks, document validation activities, and support audits. The role requires attention to detail, strong communication, and familiarity with 21 CFR Part 11, GAMP 5, URS/IQ/OQ/PQ, and modern