Validation Engineer

Flex•Austin, TX

About The Position

Flex is seeking a Validation Engineer in Austin, Texas, to ensure equipment developed and used for medical device manufacturing processes is appropriately developed, verified, and validated in accordance with Flex policies, procedures, and regulatory requirements. The role reports to the Validation Quality Manager and provides validation and quality assurance oversight for process and facilities validation and qualification activities. The Validation Engineer supports validation practices across manufacturing areas, coordinates and manages validation and control activities, and authors, reviews, and approves validation documentation. The role also supports audits, customer technical and quality matters, process improvements, and other validation areas as required by the business.

Requirements

Bachelor’s degree in engineering or a related field, or equivalent experience and training.
Six years of quality or validation experience.
Prior process and/or facilities validation experience in the medical device, pharmaceutical, or biotechnology industry.
Understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, and ISO 9001.
Working knowledge of process and facilities validation and GAMP standards.
Experience generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and incident and change management.
Experience in a quality assurance role and ability to work independently with minimal supervision.
Excellent communication, organizational, project management, and decision-making skills.

Nice To Haves

Experience working in a 24/7 operations environment.

Responsibilities

Guide and support the validation team and provide validation and quality assurance oversight for process and facilities validation and qualification activities.
Ensure validation policies and procedures are implemented and followed for medical device manufacturing, and recommend corrective actions when needed.
Implement and coordinate product assurance programs to prevent or eliminate defects in new and existing products.
Research and present information about business situations, production capabilities, manufacturing problems, economic trends, and new product design and development for management consideration.
Evaluate alternative methods and procedures to solve problems and meet business needs and changing market opportunities.
Collaborate with management personnel to formulate and establish company policies, operating procedures, and goals.
Develop and modify product assurance programs, including their areas of control, personnel requirements, and operational procedures.
Interface with customers on technical and quality issues and improvement initiatives.
Manage regulatory, compliance agency, and customer audits, serving as a subject matter expert for the applicable area or business process.
Review technical problems and procedures and recommend solutions to improve and streamline quality system processes.
Implement validation controls in manufacturing areas in accordance with applicable policies and procedures.
Execute and manage validation and control activities, including authoring, reviewing, and approving validation plans, requirement test plans, protocols and results, risk assessments, traceability matrices, and summary reports.
Monitor validation deliverables and activities to ensure regulations, protocols, procedures, and methodologies are followed and complete documentation is captured and reported.
Support other validation areas as required by the business.