Perform computer system validation (CSV) for manufacturing computers using FW Pulse, EC, and EF. Prepare and execute CSV protocols and reports, ensure installation-qualification-level testing, support FW Pulse projects, design compliant manufacturing processes/procedures, and ensure regulatory compliance for production systems.
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Perform CSV on computers that are reserved for FW Pulse and require the use of a revision of an EC or EF that is different from the one currently in use in production.
- Prepare CSV protocols, execute them, and prepare reports that demonstrate that the new computer will function exactly as intended. This means that the new version of the EC or EF, functions exactly the same as the current computers with the current version of FW, EC, and EF.
- Work with FACTORY works (FW) Pulse project.
- Use ancillary software components that work in conjunction with FW that are developed by manufacturing sites.
- The most widely used are Equipment Controller (EC) and External Functions (EF). Both of these components are validated using the Global IT MSCM Procedure.
- All documentation from MSCM is leveraged into CSV. However, CSV has one extra step that is exactly the same as an Installation Qualification process that requires having an approved protocol with representative test cases and an approved report, prior to releasing to manufacturing any computer that uses an EC o EF.
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Ensures processes and procedures are in compliance with regulations.
Qualifications:
- Bachelor’s degree in Engineering
- At least two years’ experience in regulated industry working with software and computer validations.
- Investigation and root cause analysis skills
- Technical writing knowledge
- Organization and Communication skills
- Experiences with waterfall or equivalent SDLC methodology.
- Familiar installing and troubleshooting software and peripheral equipment in Windows 10/11 computers
- Experience in medical devices or other highly regulated industry
- Strong written and verbal technical communications skills in English and Spanish.
- Capable of developing software qualification protocols and reports.
- 1st shift
Similar Jobs
Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
Review and resolve denied claims and insurance follow-up using payer portals and internal systems. Verify eligibility, contact payors, prioritize aged accounts, enter data, collaborate with teams, meet performance goals, and complete required training. Full-time with set AST hours; bilingual English/Spanish required.
Top Skills:
ExcelMicrosoft OutlookMicrosoft WordPayer PortalsWindows
Aerospace • Artificial Intelligence • Cloud • Machine Learning • Software • Cybersecurity • Defense
Design, develop, integrate, verify, and validate embedded propulsion control software for aircraft. Support requirements, architecture, coding, testing, certification, integration, customer support, and software configuration management. Work with model-based development and multiple programming languages.
Top Skills:
CC++Embedded SoftwareModel-Based Software DevelopmentPythonSoftware Configuration Management
Aerospace • Artificial Intelligence • Cloud • Machine Learning • Software • Cybersecurity • Defense
Contribute to design, development, integration, verification, and certification of aerospace propulsion control software. Responsibilities include architecture, coding, testing, V&V, customer support, and feature definition for embedded systems.
Top Skills:
CC++Embedded SoftwareModel-Based Software DevelopmentPython
What you need to know about the Austin Tech Scene
Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.
Key Facts About Austin Tech
- Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
- Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
- Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
- Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center
