Process Engineers

QRC Group, LLC; Caguas (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

QRC Group, LLC is seeking a Process Engineer with pharma-medical device experience and validation lifecycle expertise to support daily operations in a fast-paced manufacturing environment.

The role requires a Bachelor's Degree in Engineering and strong background in medical device and pharmaceutical industries, including design, execution, analysis, and close of validation protocols and reports. Availability to work in Texas is required.

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.

Responsibilities

• Root cause analysis for manufacturing issues.
• Investigations for QN/CAPA closures.
• Support both manual and automated systems/production lines.

Skills

Root cause analysis

CAPA investigations

Validation life cycle

Education

Bachelor's Degree in Engineering

Job description

We are seeking a
Process Engineer with pharma-medical device experience aswell as validations life-cycle experience (write/execute/analyze/close) tosupport the daily operations:

• Root cause analysis
• Investigation experience for QN/CAPAclosures
• Experience with manual and automated systems/lines

Requirements

• 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.
• Standard site schedule; flexible to support 24/7 operation including shifts, weekends, and holidays as operational demands requireBilingual (English and Spanish) required.
• Availability to work in Texas.