Sr. Validation Engineer

ROLE SUMMARY Reporting to the Validation Section Manager, the Sr. Validation Engineer will assure that computerized systems are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards.  The Validation Engineer will be required to become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions. The Validation Engineer will manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that CSV requirements are met.    ROLE RESPONSIBILITIES Support all aspects of Computer System Validation projects Author, execute, or review CSV documents:  Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling Manage and execute decommissioning activities Ability to work collaboratively with cross functions within the organization Represent Validation in cross functional team meetings or projects as required Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards QUALIFICATIONS 7+yearexperiencein a cGMPenvironment    4-5 years of direct validation experience Strong understanding of GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations, guidance for IQ/OQ/PQ and Standard Operating Procedures Ability to work independently with limited managerial oversight Bachelor's degree in Engineering, Science, or related field Good written and oral communication skills 4713942
Salary Range: NA
Minimum Qualification
8 - 10 years

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