Validation Quality Engineer

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Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.## ##

Job Summary To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a
** Validation Quality Engineer
** located in
** Austin, TX.
** Reporting to the Validation Quality Manager, the
** Validation Quality Engineer
** role will be responsible for equipment, facilities, and utilities validation to ensure compliance with internal policies, procedures, and regulatory requirements for medical device manufacturing.
** What a typical day looks like:
*** Provide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed.
* Implement and enforce validation policies and procedures for medical device manufacturing.
* Define qualification requirements and lead assigned validation activities to completion.
* Interface with customers on technical and quality issues, as well as improvement initiatives.
* Author and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification.
* Make independent decisions related to qualification activities.
* Evaluate alternative methods and procedures to meet business needs.
* Act as a subject matter expert during regulatory, compliance, and customer audits.
* Review technical problems and recommend solutions to improve and streamline quality system processes.
* Implement validation controls across manufacturing areas in accordance with applicable policies and procedures.
* Manage validation and change control activities by authoring, reviewing, and approving deliverables, including validation plans, test protocols/results, risk assessments, traceability matrices, and summary reports.
* Monitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation.
* Support software validation and quality engineering projects as required by business needs.
** The experience we’re looking to add to our team:
*** Typically requires a bachelor’s degree in engineering or equivalent experience and training.
* 5+ years of experience working as a validation engineer.
* 4+ years of experience in process and facilities validation within medical device, pharmaceutical, or biotechnology industries; strong understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO 9001, and GAMP standards.
* Working knowledge of validations for processes, facilities, and utilities and statistical analysis is must.
* Experience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management.
* Project management or software validation experience is a plus.
* Experience in a 24/7 operations environment strongly preferred.
** What you'll receive for the great work you provide:
*** Full range of medical, dental, and vision plans
* Life Insurance
* Short-term and Long-term Disability
*…