Validation Quality Engineer

Austin, TX - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Posting Start DateJob Posting End Date

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 dont 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 were 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 were looking to add to our team:

Typically requires a bachelors 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 youll receive for the great work you provide:

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

Job Category

Design Process & Technology Engineering

Is Sponsorship Available

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).

Job Posting Start DateJob Posting End DateFlex 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 respectfu...

Job Posting Start DateJob Posting End Date

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

Job Summary

To support our extraordinary teams who build great products and contribute to our growth were looking to add a Validation Quality Engineer located in Austin TX.

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 were looking to add to our team:

Typically requires a bachelors 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 youll receive for the great work you provide: