Pharma/Medical Device Process Engineer — Validation & CAPA

QRC; San Juan (PR); On-site; USD 85,000 - 105,000; Full time

Job summary

QRC Group, LLC is seeking a Process Engineer with pharma-medical device experience to support validation life cycle activities (design, execute, analyze, and close protocols/reports) in daily manufacturing operations.

The role includes root cause analysis, investigations and CAPA closures for both manual and automated lines, with flexibility for a fast-paced 24/7 environment and Texas work availability.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
• Strong experience in the Medical Device industry (required).
• Pharmaceutical industry experience (preferred).
• Demonstrated experience with validation life cycle activities (design, execute, analyze, and close protocols/reports).
• Experience performing root cause analysis and implementing solutions.
• Experience supporting investigations, QN, and CAPA closures.
• Experience working with manual and automated manufacturing systems/production lines.
• Ability to work effectively in a fast-paced manufacturing environment.
• Bilingual (English and Spanish) required.
• Availability to work in Texas.

Responsibilities

• Perform root cause analysis and investigations.
• Support validation life cycle activities (design, execute, analyze, close protocols/reports).
• Assist with QN and CAPA closures for manufacturing lines (manual & automated).

Skills

Root cause analysis

CAPA closures

Validation life cycle

Manual & automated lines

Investigations

Bilingual EN/ES

Texas availability

Pharma/Med device

Education

Bachelor's in Engineering

Job description

QRC Group, LLC is seeking a Process Engineer with pharma-medical device experience to support validation life cycle activities (design, execute, analyze, and close protocols/reports) in daily manufacturing operations.

The role includes root cause analysis, investigations and CAPA closures for both manual and automated lines, with flexibility for a fast-paced 24/7 environment and Texas work availability.