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Software Validation Engineer at Flex

Posted in Architecture 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Buffalo Grove, Illinois





Job Description:

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


  • NASDAQ: FLEX


  • Headquarters: 2 Changi South Lane, Singapore, 486123


  • Company Size: 10,001+ employees


  • Website: www.flex.com

Job Description

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:


  • Intense collaboration

  • 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

  • Life Insurance

  • Matching 401K

  • PTO

  • Tuition Reimbursement

  • Employee discounts at local retailers

Job Category

Quality

Flex 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: accesibility@flextronics.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.

The information we collect:

We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.

If you have any queries about the processing of your data, please contact:

 

Global Data Privacy Officer:

Email Address: chiefprivacyofficer@flex.com





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