Computer System Validation Specialist
1 week ago
Job Summary:
The Computer System Validation (CSV) Specialist will support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the manufacturing facility but may require some travel to other North American sites as needed.
Key Responsibilities:
- Collaborate with the Data Integrity Manager to validate automated equipment and control systems.
- Execute test scripts, create, and modify draft protocols to ensure compliance with regulatory requirements.
- Review previously executed CSV activities, identify gaps, and update GMP documentation revisions.
- Support the creation and modification of validation documentation to ensure accuracy and completeness.
- Write reports summarizing the results of protocol executions, highlighting key findings and recommendations.
Requirements:
- Bachelor's degree in computer science, engineering, or a related field.
- Minimum of 2-3 years of experience working with automation and/or computerized system validations.
- Direct experience in validation of computer/automation/software validation, including IQ, OQ, PQ protocol preparation, deviation resolution, and final summary report preparation.
- Strong written and oral communication skills, with the ability to effectively communicate with cross-functional teams.
- Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
- Experience working in a GXP environment, with a strong understanding of regulatory requirements.
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