What are the responsibilities and job description for the Validation Senior Engineer position at Flex?
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 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.
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Validation Senior Engineer located in Austin, TX.
Reporting to the Quality Manager, the Validation Senior Engineer will support our extraordinary teams who build great products and contribute to our growth. Responsible for process validations to ensure that the equipment used for medical device manufacturing process are appropriately developed, qualified to meet Flex’s internal policies, procedures and regulatory requirements.
What a typical day looks like:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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 accessibility@flex.com 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).
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Validation Senior Engineer located in Austin, TX.
Reporting to the Quality Manager, the Validation Senior Engineer will support our extraordinary teams who build great products and contribute to our growth. Responsible for process validations to ensure that the equipment used for medical device manufacturing process are appropriately developed, qualified to meet Flex’s internal policies, procedures and regulatory requirements.
What a typical day looks like:
- Provide validation oversight on process 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.
- Determine and establish requirements for qualification activities and lead all assigned qualification activities to completion.
- Suggests, debates alternative methods and procedures in solving problems to meet business needs.
- Make independent decisions related to qualification activities.
- Author / execute validation plans, protocols (IQ, OQ, TMV, and PQ protocol) and other validation deliverables to support equipment qualifications and re-qualification activities.
- 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; 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, manages validation and change 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 area 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 software or facilities validations as deemed necessary by business.
- Bachelor’s (in engineering, sciences or related field)
- 6 years of validation experience.
- Prior process validation experience working in medical device, pharmaceutical or biotechnology industry with understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001, GAMP standards.
- Experience in generating, review and approval of validation deliverables, statistical analysis, risk management, incident and change management.
- Project management or software / facilities validation experience is a plus.
- 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 celebrate diversity and 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 accessibility@flex.com 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).
