GMP Quality Engineering Support Specialist

Veg Group

Carolina (PR)

On-site

USD 60,000 - 95,000

Full time

2 days ago

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Job summary

Validation & Engineering Group, Inc. seeks a Quality Engineering Support Specialist for the PR05 site in Puerto Rico.

You will provide technical and documentation support to QA engineers, focusing on facilities, utilities, maintenance, and qualification activities to ensure regulatory compliance and data integrity. You must be bilingual (English/Spanish) and ready to support 24/7 operations when required, with established experience in GMP environments and GDP practices.

Qualifications

Bachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical).
Minimum five years in automated GMP operations with facilities, utilities, maintenance, and quality systems.
Strong writing and knowledge of GDP and data integrity.

Responsibilities

Serve as a technical resource for assets, utilities, and processes to support compliant deliverables.
Monitor qualified utilities performance against quality requirements and regulations.
Support maintenance, engineering, and qualification activities and strategies.
Assist investigations and root cause analysis led by QA engineers.
Support change controls development and implementation.
Ensure documentation meets GDP and data integrity requirements.
Notify QA management of significant quality issues promptly.