Validation Analyst
Id: AT00131
2023-12-11
JOB ID 10822: Validation Analyst
Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.
Job duties include:
l Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.
l Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.
l Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.
l Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.
l Developing test strategies and plans for the execution of operational and performance protocols.
l Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.
l Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action Preventive Action (CAPA) for deviations observed during the execution of validation protocols.
l Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.
l Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.
Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.