Perform computer system validation for FACTORYworks Pulse manufacturing computers and related Equipment Controller and External Functions software. Prepare and execute validation protocols and reports, investigate issues, perform root cause analysis, install and troubleshoot Windows software and peripherals, and ensure manufacturing processes comply with regulations. The role also supports manufacturing process and procedure design in a highly regulated pharmaceutical, biotech, medical device, or manufacturing environment.
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
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