IT Software Validation Engineer
IT Software Validation Engineer
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1 Vacancy
Job Description
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 fulltime 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).
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/customers requirements.
- Resolve required improvements on the systems & supervise its correct implementation to meet site business/customers requirements.
- Communicate with users to troubleshoot and resolve day to day system issues to ensure smooth operation.
Qualifications:
- 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.
Key Competencies:
- 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)
Skill Capabilities:
- IT Software Change Management coordination and teamwork with System Owners Process Owners Software Quality Quality Operations and technical SMEs.
- IT Software Validation Engineer working with QA Software Validation Engineers and SMEs to complete the validation documents deliverables review and sign the SIQs Software Verifications Software Validation Protocols and Reports.
- Use SDLC / GAMP 5 methodology for Risk based approach to software validation.
What youll receive for the great work you provide:
- Full range of medical dental and vision plans
- Life Insurance
- Shortterm and Longterm Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
Job Category
ITIs Sponsorship Available
NoFlex 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. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well 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).Employment Type
Full-Time
