Validation Engineer

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 are looking to add a Validation Engineer located in Austin TXThe position shall be reporting into the Validation Quality Manager the Validation Engineer will be responsible for ensuring that the equipment developed and used for medical device manufacturing processes are appropriately developed, verified, and validated to meet Flex’s internal policies, procedures and regulatory requirements.

Here is a glimpse of what you’ll do:

Guide and support the validation team, provide validation and QA oversight on process / facilities validation and qualification activities to ensure compliance and recommend appropriate corrective actions as needed.

Assure validation policies and procedures are implemented and followed for medical device manufacturing.

Implements and coordinates product assurance programs to prevent or eliminate defects in new or existing products.

Researches, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.

Suggests, debates alternative methods and procedures in solving problems to meet business needs and changing market opportunities.

Collaborate with other management personnel in formulating and establishing company policies, operating procedures and goals.

Develops initial and subsequent modifications of product assurance program to delineate areas of control, personnel requirements and operational procedures within program.

Interface with customers on technical/quality issues and improvement initiatives.

Responsible for managing regulatory/compliance agency/customer audits by acting as an SME for the respective area / business process.

Reviews technical problems and procedures and recommends solutions to improve and streamline the existing quality system processes.

Implement practices around validation controls for all manufacturing areas in line with applicable policies and procedures.

Executes and manages validation and control activities by authoring, reviewing, and approving validation deliverables, including but not limited to validation plans, requirement test plans/protocols/results, risk assessments, traceability matrices, and summary reports.

Monitor validation deliverables and activities for assigned areas to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.

Additionally required to support other areas of validation as deemed necessary by business.

Here is some of what you’ll need:

Typically requires bachelor’s degree in engineering or related field or equivalent experience and training.
6 years of Quality/ Validation experience

Prior process and/or facilities validation experience working in medical device, pharmaceutical or biotechnology industry with understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO
9001.Working knowledge of process, facilities validations and GAMP standards.

Experience in generating, reviewing and approval of validation deliverables, statistical analysis, risk management, incident and…