Validation Engineer

Flex•Austin, TX

12d

About The Position

Flex is seeking a Validation Engineer in Austin, Texas, to ensure equipment developed and used in 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 supports validation teams and manufacturing areas through validation and quality oversight, documentation, regulatory compliance, and customer and agency audit support. The engineer may also support other validation areas as business needs require.

Requirements

Typically requires a 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, and with statistical analysis, risk management, incident management, and change management.
Experience in a prior quality assurance role.
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, providing validation and quality assurance oversight for process and facilities validation and qualification activities, and recommend corrective actions as needed.
Ensure validation policies and procedures are implemented and followed for medical device manufacturing.
Implement and coordinate product assurance programs to prevent or eliminate defects in new or existing products.
Research and present information on business situations, production capabilities, manufacturing problems, economic trends, and product design and development for management consideration.
Evaluate alternative methods and procedures to solve problems and address 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, defining 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 relevant area or business process.
Review technical problems and procedures and recommend solutions to improve and streamline quality system processes.
Implement validation controls across manufacturing areas in line with applicable policies and procedures.
Execute and manage validation and control activities by authoring, reviewing, and approving validation deliverables, including plans, requirement test plans, protocols, results, risk assessments, traceability matrices, and summary reports.
Monitor validation deliverables and activities in assigned areas to ensure applicable regulations, protocols, procedures, and methodologies are followed and complete documentation is captured and reported.
Support other validation areas as required by the business.