Senior Process Engineer – Pharma & Medical Devices

Quality Consulting Group, LLC

Juncos (PR)

On-site

USD 90,000 - 120,000

Full time

4 days ago

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Job summary

QUALITY CONSULTING GROUP in Puerto Rico and the USA is seeking a talented engineer to join our team, providing technical and process-development support across pharmaceutical, biotech, medical-device and manufacturing operations. You will collaborate with cross-functional teams to drive process improvements, support technology transfers, and ensure GMP-compliant operations.

The role emphasizes root-cause analysis, qualification and validation activities (IQ/OQ/PQ), data analysis, and

Qualifications

Bachelor's degree in Engineering required.
4 years of engineering experience in pharma/biotech or medical devices.
Experience with sterile injectable products and packaging is preferred.

Responsibilities

Provide technical and process-development support to manufacturing operations.
Support process qualification and validation activities (IQ/OQ/PQ).
Investigate rejects, defects, yield losses, alarms, and deviations.
Develop and maintain technical documentation (protocols, reports, change controls).
Analyze process data and monitor performance using statistical methods.
Collaborate with Manufacturing, QA, QC, Engineering, Validation, Maintenance, and Regulatory Affairs.
Provide on-the-floor technical assistance and troubleshooting.
Ensure GMP compliance and data-integrity requirements.