Validation Engineer

at FedEx Logistics in Memphis, Tennessee, United States

Job Description

About FedEx Supply Chain

FedEx Supply Chain, a subsidiary of FedEx Corp. (NYSE: FDX), is a leader in the third-party logistics industry offering a diverse service portfolio that enables commerce for businesses. With a proven track record of innovation and operational excellence, FedEx Supply Chain takes a consultative approach to optimize logistics processes, implement innovative technology and drive continuous improvement. By leveraging best practices and the world-renowned FedEx network, FedEx Supply Chain delivers leading solutions that provide flexibility, enable scalability and improve cost-effectiveness for customers. Through more than 11,000 employees, 130 operations and 35 million square feet of warehouse space, FedEx Supply Chain manages nearly 150 million packages and processes 358 million returns each year. For more information, go to We Have….

+ A strong FedEx brand consistently ranked among the world’s most admired and trusted employers.

+ A top notch leadership team with the experience needed to grow and develop your career.

+ An open mind for new ideas and creative methods.

+ A strong compensation and benefits package, including health, vision, dental, 401k with a strong match and much more!

General Summary…. The Validation Engineer tests and verifies processes and equipment to verify their intended use in regulated environments across the FedEx Supply Chain network. Validation Engineers develop, document, and implement Validation protocols for hardware, software, and processes. They inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines, computer software and procedures. Create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This position will be responsible for…..

+ Generate and maintain site specific Master Validation Plan for all affected locations

+ Lead validation projects and complete all associated project documentation in line with regulatory expectations

+ Manage, coordinate and guide the execution of the site validation master plan

+ Provide the relevant support for regulatory audits, submissions and other auditor requests

+ Populate validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria)

+ Develop and run test protocols

+ Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc

+ Develop, write, and maintain commissioning, qualification and validation documents following established standards and templates.

+ Perform and conduct verification of system drawings

+ Ensure the validation status of equipment and systems are in compliance with cGMPs at all times.

+ Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments

+ Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists

+ Maintain validation documentation through the validation lifecycle

+ Provide evidence of both internal and external regulatory compliance

+ Troubleshoot in the event of abnormal testing results

+ Troubleshoot issues identified by other staff members

+ Ensure accurate records of all validation activities

+ Supervise junior staff or management of a team of validation professionals

You might be a great fit if…. Education/Experience

+ Bachelor’s Degree in Engineering or other technical field preferred and at least 4 years of experience using advanced quality engineering tools in a fast-paced environment.

+ In lieu of degree, high school diploma or GED and at least 6 years of relevant experience.

+ Must have strong working understanding of Validation and compliance with cGMPs.

+ Must have strong working knowledge of Six Sigma and Lean Manufacturing concepts.

+ Working knowledge of QDM tools preferred.

+ Strong organizational skills.

+ Experience with customer contact, and voice of the customer capture.

+ Prior experience working in a continuous process improvement environment required.

+ High level of flexibility to perform in a fast-paced environment.

+ Familiarity with Quality System Standards such as ISO 9001, TL9000, & ISO 13485.

+ Proven ability to manage multiple tasks and meet complex deadlines.

+ Must be able to motivate teammates, and lead project teams.

Physical/Cognitive Requirements With or without accommodation:

+ Ability to follow policies and procedures.

+ Ability to read, write and interpret information.

+ Ability to add, subtract, multiply and divide.

+ Ability to use hands to finger, handle, or feel.

+ Ability to sit/walk/stand for up to 8 hours per day.

+ Must possess visual acuity, i.e., close, distance, and color vision, depth perception and the ability to adjust focus.

ADA – FedEx Supply Chain will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. Reasonable accommodations are available for qualified individuals with disabilities throughout the subsequent application process. Fed Ex Supply Chain is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. Job ID: 38250

Schedule: Full-time

Requsition ID: 38250

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Job Posting: JC194922960

Posted On: Oct 15, 2021

Updated On: Nov 08, 2021