Manufacturing CSV Engineer I

Medial Group; Puerto Rico; On-site; USD 75,000 - 95,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico, seeks a Manufacturing Engineer I to support the FACTORYworks Pulse project by performing Computer Software Validation (CSV) for manufacturing software and computer systems in regulated environments.

You will develop validation protocols, run tests, document results, and assist EC/EF implementations under Global IT MSCM and local CSV rules. Collaboration with engineering and operations is essential to minimize production disruption.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Computer, Chemical, Industrial or related).
• Minimum 3 years in regulated industries supporting software and computer system validations, including protocol development and documentation.

Responsibilities

• Execute CSV activities for software and computer equipment supporting FACTORYworks Pulse.
• Develop, execute, and document validation protocols, tests, and summary reports.
• Support EC and EF validation activities under Global IT MSCM and local CSV requirements.
• Perform IQ-type activities and assist protocol approvals prior to software deployment.
• Investigate, troubleshoot, and perform root cause analysis related to software performance and validation.

Skills

CSV

Validation protocols

IQ/OQ/PQ

Regulatory compliance

Technical writing

Bilingual EN/ES

Education

Bachelor’s degree in Engineering

Tools

MES systems

FW Pulse

Windows 10/11

Job description

Medial Group in Villalba, Puerto Rico, seeks a Manufacturing Engineer I to support the FACTORYworks Pulse project by performing Computer Software Validation (CSV) for manufacturing software and computer systems in regulated environments.

You will develop validation protocols, run tests, document results, and assist EC/EF implementations under Global IT MSCM and local CSV rules. Collaboration with engineering and operations is essential to minimize production disruption.