Pharma-Device Process Engineer: Validation & RCA Lead

QRC Group, Inc; Caguas (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC is seeking a Process Engineer with pharma-medical device experience and validations lifecycle expertise to support daily operations. The role requires root cause analysis, QN/CAPA closures, and experience with manual and automated systems/lines.

This position is based in Texas with a standard site schedule and potential for 24/7 support as operational demands require. Bilingual (English and Spanish) is required.

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
• Strong Medical Device industry experience (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

• Root cause analysis and investigations for QN/CAPA closures.
• Experience with validation life cycle activities (design, execute, analyze, close).
• Support daily operations on manual and automated manufacturing lines.

Skills

Root cause analysis

Validation lifecycle

Manual and automated lines

Education

Bachelor's Degree in Engineering

Job description

QRC Group, LLC is seeking a Process Engineer with pharma-medical device experience and validations lifecycle expertise to support daily operations. The role requires root cause analysis, QN/CAPA closures, and experience with manual and automated systems/lines.

This position is based in Texas with a standard site schedule and potential for 24/7 support as operational demands require. Bilingual (English and Spanish) is required.