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About the Role
Full Time Contract Role: CSV Specialist Location: 100% Onsite Barcelonets, PR Length of Contract: 6+ Months Position Description
The CSV Specialist is responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full system lifecycle. This role ensures that computerized and automated manufacturing equipment comply with our client CSV Standard Procedures, FDA 21 CFR Part 11 , and GAMP 5 guidelines.
Responsibilities
+ Lifecycle Documentation: Author, review, and execute validation deliverables including Validation Plans, User Requirement Specifications (URS), Functional Requirements (FRS), Risk Assessments (FRA/DRA), IQ/OQ/PQ protocols, and Traceability Matrices (TM).
+ System Compliance: Perform 21 CFR Part 11 and Data Integrity (ALCOA+) assessments for standalone and networked systems
+ Process Support: Support the implementation of project initiatives at the Manatí site, specifically ...
The CSV Specialist is responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full system lifecycle. This role ensures that computerized and automated manufacturing equipment comply with our client CSV Standard Procedures, FDA 21 CFR Part 11 , and GAMP 5 guidelines.
Responsibilities
+ Lifecycle Documentation: Author, review, and execute validation deliverables including Validation Plans, User Requirement Specifications (URS), Functional Requirements (FRS), Risk Assessments (FRA/DRA), IQ/OQ/PQ protocols, and Traceability Matrices (TM).
+ System Compliance: Perform 21 CFR Part 11 and Data Integrity (ALCOA+) assessments for standalone and networked systems
+ Process Support: Support the implementation of project initiatives at the Manatí site, specifically ...
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