2-5 years of experience in Computer System Validation with Temperature Mapping
• Develops validation plans, and qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that systems are qualified in accordance with applicable regulatory agencies.
• Assures that all validation documentation meets or exceeds the regulatory expectations.
• Hands-on experience with validation of equipment and computer system validation for Computerized Systems.
• Able to work with minimal assistance and supervision on validation discrepancies or investigations.
• Performs temperature mapping studies.
• Perform other duties as assigned.
Qualifications:
• Hands-on experience in equipment and computer systems, including qualification of Controlled temperature units.
• Strong understanding of regulatory standards and documentation practices.
• Ability to work independently, manage multiple priorities, and resolve validation issues.
• Excellent analytical, and technical writing skills.
