Process Engineers

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 a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

We are seeking aProcess Engineerwith pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:

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

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.
• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Job Location