Validation Quality Engineer

Flex • Austin, TX

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About The Position

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.

Requirements

• 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.

Nice To Haves

• Project management or software validation experience is a plus.
• Experience in a 24/7 operations environment strongly preferred.

Responsibilities

• 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.

Benefits

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees