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
