Computer System Validation Specialist
3 days ago
The Computer System Validation (CSV) Specialist role at JobRialto supports the Newark manufacturing facility with the validation of new and existing computerized systems. This position requires strong technical skills and experience in automation and computer system validations.
This role will primarily support the Newark manufacturing facility but may require occasional travel to other North American sites as needed.
Key Responsibilities:
- Support the Data Integrity Manager with the validation of automated equipment and control systems.
- Execute test scripts, create, and modify draft protocols.
- Review previously executed CSV activities, identify gaps, and update GMP documentation.
- Support the creation and modification of validation documentation.
- Write reports summarizing the results of protocol executions.
Requirements:
- Bachelor's degree in computer science, engineering, or a related field.
- Minimum of 2-3 years of experience in automation and/or computer system validations.
- Direct experience in validation of computer/automation/software validation, including IQ, OQ, PQ protocol preparation, deviation resolution, and final summary report writing.
- Strong written and oral communication skills.
- Strong organizational and time management skills.
- Experience working in a GXP environment.
Education:
Bachelor's Degree in a relevant field.
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