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.