CSV Engineer – Computerized Systems Validation | Medical Device Industry

Computerized Systems Validation (CSV) Engineers for potential opportunities supporting regulated medical device manufacturing operations in Puerto Rico.
We are seeking motivated engineering professionals with strong technical knowledge of computerized systems validation, quality compliance, and FDA-regulated manufacturing environments.

About Scientific Safety Alliance

Scientific Safety Alliance (SSA)

This opportunity may involve supporting validation activities associated with manufacturing systems, technology implementation, and operational expansion initiatives.
Develop, execute, and maintain computerized systems validation protocols and documentation.
Prepare and review validation deliverables, including User Requirements Specifications (URS), risk assessments, traceability matrices, and IQ/OQ/PQ protocols.
Support validation of computerized manufacturing, laboratory, and quality systems, as applicable.
Ensure validation activities comply with applicable FDA requirements, 21 CFR Part 11, 21 CFR Part 820 (QMSR), and ISO 13485.
Collaborate with Engineering, Quality Assurance, IT, Automation, and Manufacturing teams.
Support validation testing, discrepancy investigations, corrective actions, and change control processes.
Maintain accurate, complete, and audit-ready validation documentation.
Assist with computerized system implementation, upgrades, and ongoing compliance.
Supporting Quality, Engineering & Excellence in Regulated Industries

Knowledge of FDA 21 CFR Part 11, ISO 13485, and GAMP 5 principles.
Strong technical writing, documentation, analytical, and problem-solving skills.
Ability to collaborate across multidisciplinary engineering and quality teams.
We are currently building our candidate pipeline while finalizing additional project and employment details.

Bachelor's degree in Engineering, Computer Science, or a related technical discipline preferred.
Experience in Computerized Systems Validation (CSV) within FDA-regulated environments.
Experience in medical device manufacturing highly preferred.
Familiarity with IQ/OQ/PQ, validation lifecycle documentation, and risk-based validation methodologies.
English and Spanish communication skills preferred.
Experience with manufacturing execution systems (MES), laboratory information management systems (LIMS), electronic quality management systems (eQMS), or other computerized systems used in regulated manufacturing.

Qualified professionals are encouraged to submit their résumés for consideration.

joseph@scisafetyalliance.com