New York Blood Center

Senior Validation Engineer

US-NY-Long Island City
Job ID
2017-1729
Category
Information Technology
Type
Regular Full-Time

Overview

At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

Responsibilities

Provide competent and comprehensive validation and documentation for applications of the National Cord Blood Program (NCBP). Perform computerized systems validation by following FDA guidelines: 21 CFR Part 11 and maintain comprehensive and accurate records and detailed documentation; perform validation activities using the V-model and risk based approach as defined in GAMP5. Perform GMP assessments and functional risk assessments to determine the extent of validation of a given application/change would require; create, review and perform IQ/OQ/PQ protocol execution and related testing for the NCBP applications. Perform the change request procedure by filing of the change request forms for NCBP IT. Gain an understanding of operations, user needs to design user, functional and design specification to provide knowledge for internal interfaces by working with diverse end users across the company. Acquire an understanding of NCBP systems and monitor changes in procedures to ensure system continuity. Complete IT projects by conducting monthly meetings with organizational business units to determine the need for new projects. Create and maintain up-to-date meeting minutes for change control meetings. Complete NCBP projects by performing validation for the assigned NCBP application in a regulated environment and by ensuring the FDA requirements are met. Maintain validation logbook for NCBP department. Maintain accurate and up-to-date validation documentation for vendor provided systems application and be responsible for maintaining the regular calibration of various equipment. 

Qualifications

Must have a Master’s degree in life sciences, pharmaceutical engineering or related field, and three years of experience developing validation processes, procedures and using V-model. Must have one year of experience with FDA guidelines that include 21 CFR Part 11, and with GAMP 5 risk based approach.

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