Computer System Validation Specialist
Wilmington, Delaware
Computer System Validation Specialist
Wilmington, DE
Pay Rate: $40-$45/hour
The Computer System Validation is going to support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the Newark manufacturing facility but may require some travel to other North American sites as needed.
Computer System Validation Primary Responsibilities
Wilmington, DE
Pay Rate: $40-$45/hour
The Computer System Validation is going to support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the Newark manufacturing facility but may require some travel to other North American sites as needed.
Computer System Validation Primary Responsibilities
- Support Data Integrity Manager with validation of automated equipment and control systems.
- Responsible for execution of test scripts, creating, and modifying draft protocols
- Responsible for reviewing previously executed CSV activities, identify gaps, including GMP documentation revisions
- Support with creating and modifying validation documentation
- Write reports which summarize the results of the protocol executions.
- Bachelor’s degree required, preferred in computer science, engineering, or other sciences.
- Minimum of 2-3 years of experience working with automation and/or computerized system validations.
- Must have direct experience in validation of computer/automation/software validation (prepare IQ, OQ, PQ protocol, resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 / 210 / 211.
- Strong written and oral communication skills.
- Strong organizational and time management skills.
- Experience working in a GXP environment.
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