Pharma/MedDevice Process Engineer — Validation & CAPA

QRC Group, Inc; San Juan (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

QRC Group, LLC, a firm serving the Pharma, Medical Devices and Chemical industries in validation and regulatory fields, seeks a Process Engineer with pharma/medical device experience and validation lifecycle expertise to support daily operations.

The role requires root cause analysis, CAPA closures, and experience with both manual and automated manufacturing lines in a fast-paced environment; bilingual English/Spanish is required; availability to work in Texas is needed.

Qualifications

• Bachelor's degree in engineering required.
• Strong experience in the Medical Device industry.
• Pharmaceutical industry experience preferred.
• Experience with validation life cycle activities.
• Experience supporting investigations, QN and CAPA closures.
• Experience working with manual and automated manufacturing systems.

Responsibilities

• Root cause analysis and implementation of solutions.
• Investigations and CAPA closures (QN/CAPA).
• Support both manual and automated manufacturing lines in a fast-paced environment.

Skills

Root cause analysis

CAPA investigations

Validation life cycle

Manual and automated manufacturing

Bilingual English/Spanish

Pharma/Medical device experience

Education

Bachelor's Degree in Engineering

Job description

QRC Group, LLC, a firm serving the Pharma, Medical Devices and Chemical industries in validation and regulatory fields, seeks a Process Engineer with pharma/medical device experience and validation lifecycle expertise to support daily operations.

The role requires root cause analysis, CAPA closures, and experience with both manual and automated manufacturing lines in a fast-paced environment; bilingual English/Spanish is required; availability to work in Texas is needed.