Process Engineers
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QRC Group
Caguas
Summary
The Process Engineer will support daily manufacturing operations by performing root cause analysis and managing investigations for QN and CAPA closures. They are responsible for the full validation life-cycle, including designing, executing, and analyzing protocols for both manual and automated systems.
Job Description
We are seeking a Process Engineer with 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
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.
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
Founded
2005
Company size
51-200 employees
Industry
Staffing and Recruiting
Org type
Privately Held
Headquarters
Caguas, PR
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
Founded
2005
Company size
51-200 employees
Industry
Staffing and Recruiting
Org type
Privately Held
Headquarters
Caguas, PR
