Flex is a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live Smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information please visit our careers page at www.flex.com.
Industry: Electrical / Electronic Manufacturing
Type: Public Company
Headquarters: 2 Changi South Lane, Singapore, 486123
The Software Validation Engineer will be based in Buffalo Grove, IL. This role will provide expertise in Software Validation to establish and maintain the validated state of the Corporate-wide Systems utilized on different Flex Medical Sites. This role will partner cross-functionally with Business, IT, Production Implementation group, and other engineering groups in the design, development, launch, and validation of new and upgrading Computer Software Systems.
We are looking for someone who demonstrates:
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you’ll do:
Analyzes, and presents the validation strategy for software used to enhance/upgrade, business execution, production manufacturing process, concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, design and development of new / upgrading software solutions.
Suggests and debates alternative methods and procedures in solving problems and meeting regulatory requirements.
Responsible to establish the CSV procedures used in projects to ensures the relevant computer systems are in compliance with applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11, 820 and Annex 11.
Overseeing and executing the validation of new systems; evaluating and performing periodic reviews of existing validated systems and maintaining required change control procedures to ensure the state of software validation.
Prepare and maintain CSV deliverables for software running in the corporate or the facility to ensure they are all adequately validated projects for used and undertaken within Flex Medical.
Educate/train the facility stakeholders about organization policy & procedures related to CSV
Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
Maintain a validated state under Software Validation procedures / Master Plan document as needed.
Assist with determination of root cause, impact, and resolution of problems impacting production.
Here is some of what you’ll need (required):
B.S./M.S. in a computer science or related engineering/science field with multiple computer-systems programming experience with at least 6 years of relevant experience and at least 3-5 years as Subject Matter Expert in a software CSV or GAMP guidelines implementation.
Experience in the medical device or pharmaceutical industry in product development, software validation, quality management, process controls, document controls, and continuous improvement methods.
Experienced with various IT SDLC, GAMP Software Validation.
Provide software SDLC (Software Development Life Cycle) and validation expertise with regulatory compliance guidance and direction in order to meet with, and applicable regulations for computerized systems with the Flex Global IT as well as Flex Health Solutions organizations.
Here are a few of our preferred experiences:
ASQ accreditation (CSQE, CQE or CMQ/OE).
Experience with Microsoft Office, Microsoft Project, Visual Studio, SAP/ERP, and Manufacturing Execution Systems.
Experience working on multiple projects simultaneously.
Experience in medical device/equipment validation
Experience in FDA Audit support/involvement
Here are a few examples of what you’ll get for the great work you provide:
Full range of medical benefits, dental, vision
Employee discounts at local retailers
QualityFlex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices 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. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: email@example.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
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