Validation Engineer

Flex; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Flex is seeking a Validation Engineer in Austin, TX to lead validation and QA oversight for medical device manufacturing. You will develop and review validation plans, protocols, risk assessments, and summary reports while ensuring CFR Part 820/11 and ISO 13485 compliance.

Role requires 6+ years in quality/validation, strong communication, and ability to work independently in a 24/7 environment. On-site posting with opportunities to influence product assurance programs and audits.

Qualifications

• 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 in medical device/pharma/biotech with CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001.
• Working knowledge of process, facilities validations and GAMP standards.
• Experience generating, reviewing and approving validation deliverables, statistical analysis, risk management, incident and change management.
• Experience in a prior quality assurance role and ability to work independently with minimal supervision.
• Excellent communication, organizational, project management and decision-making skills.
• Experience in 24/7 operations environment strongly preferred.

Responsibilities

• Guide and support the validation team, provide validation and QA oversight on process/facilities validation and qualification activities to ensure compliance and recommend corrective actions.
• 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, evaluate and present information on business situations, production capabilities, manufacturing problems, and design and development of new products.
• Suggest and debate alternative methods and procedures to meet business needs and changing market opportunities.
• Collaborate with management to formulate and establish company policies, procedures and goals.
• Develop initial and subsequent modifications of product assurance program to delineate areas of control and procedures.
• Interface with customers on technical/quality issues and improvement initiatives.
• Manage regulatory/compliance audits as SME for the area/ process.
• Review technical problems and procedures and recommend solutions to improve QA systems.
• Implement validation controls across manufacturing areas per policies.
• Author, review and approve validation deliverables (plans, protocols, risk assessments, traceability, reports).
• Monitor validation deliverables/activities to ensure compliance and complete documentation.
• Support other validation areas as needed.

Skills

Quality/Validation

Process validation

Regulatory knowledge

Communication

Project management

Independent work

24/7 operations experience

Education

Bachelor's degree in engineering

Tools

GAMP standards

Job description

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.

We are looking to add a Validation Engineer located in Austin TX. The 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, ISO9001.
• Working knowledge of process, facilities validations and GAMP standards.
• Experience in generating, reviewing and approval of validation deliverables, statistical analysis, risk management, incident and change management.
• Experience in a prior quality assurance role and ability to work independently with minimal supervision.
• Excellent communication, organizational, project management and decision-making skills.
• Experience working in 24/7 operations environment strongly preferred.

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. We’re happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [e-mail] and we’ll 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).