JT040 - MANUFACTURING SOFTWARE ENGINEER I

Job summary

Qua***, 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.

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

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.
• 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.

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