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
Skills Required
- 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
- Experience with waterfall or equivalent SDLC methodology
- Familiarity installing and troubleshooting software and peripheral equipment on Windows 10/11
- 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
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
