Validation Engineer

Flex•Buffalo Grove, IL

About The Position

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’re looking to add a Validation Engineer located in Buffalo, IL Reporting to the Quality Manager, the Validation 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.

Requirements

3+ years of validation experience ( process and product validation)
3+ years of 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.

Nice To Haves

Software validation experince prefer

Responsibilities

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.