Please reply at rsmith@bestrecruitingsolutions.com
Validation Engineer
5 month contract
McPherson, KS
$35/Hour Max
Reporting to the Validation Section Manager, the 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
Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards
QUALIFICATIONS
5+ year experience in a cGMP environment
3+ years of direct computer system validation experience
Bachelor's degree in Engineering, Science, or related field
Strong understanding of GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures
Ability to work independently with limited managerial oversight
Good written and oral communication skills
If you're not interested, please share the requirement with your friends/colleague and we will pay you referral fee once candidate get placed.
Regards,
Robin Smith l Staffing Manager
Carrollton, TX l Best Recruiting, Inc.
972-348-9746
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