Job Posting Start Date 05-13-2025 Job Posting End Date 07-14-2025
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
Summary:
The IT Software Validation Engineer will be based in Libertyville, IL reporting to the IT Software Validation Manager.
In this newly created, full-time role, you will be exploring complex business process with automated, customized, developed and standardize IT systems implementations and solutions. You will be responsible for the software validation of the designed details for IT systems and ensure compliance with software regulations and requirements. You will be working with stakeholders (internal and external).
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Responsibilities:
- Understand complex business process.
- In charge of IT Computer Software Assurance for a mayor Customer Onboarding.
- Identify, evaluate, and validate IT systems by following procedures and best practices.
- Research, design and test new systems and system enhancements in line with the deliverables of site business/customer's requirements.
- Resolve required improvements on the systems & supervise its correct implementation to meet site business/customer's requirements.
- Communicate with users to troubleshoot and resolve day to day system issues to ensure smooth operation.
- Functional knowledge, education background on Systems or industrial engineer, Computer science, programming, or related careers; or relevant working experience required.
- Typically requires 6- 8 years of related experience from medical device manufacturing company and/or pharmaceutical company.
- Demonstrates advanced functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills. Demonstrates advanced skills in functional/ technical area.
- Good understanding of systems and functionalities in place.
- Software Validation.
- 21 CFR 820.
- 21 CFR Part 11, Electronic Records; Electronic Signatures
- Software Validation (Computer Software Validation (CSV))
- Manufacturing End to End Process interpretation and understanding to apply and run Software Validation task and activities
- Software Quality reviews and systems audits
- Software compliance and Gap assessments
- MES (Manufacturing Execution Systems/Shopfloor systems) Validation (like FlexFlow, MES Pro or equivalent)
- Risk Management
- GxP Standards and Compliance (GAMP5)
- Quality Systems Regulations (FDA)
- ISO13485 understanding and compliance for IT
- Failure Modes Analysis (FMEA)
- IT Software Change Management coordination and teamwork with System Owners, Process Owners, Software Quality, Quality Operations and technical SME's.
- IT Software Validation Engineer working with QA Software Validation Engineers and SMEs to complete the validation documents deliverables, review and sign the SIQ's, Software Verifications, Software Validation Protocols and Reports.
- Use SDLC / GAMP 5 methodology for Risk based approach to software validation.
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
$70,400.00 USD - $96,800.00 USD Annual
Job Category
IT
Is Sponsorship Available?
No
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 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).