We are seeking an Engineer with e xperience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry Duties: Proficiency in technical report writing. Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques. Strong problem-solving skills and experience conducting root cause investigations. Expertise in identifying and managing Corrective and Preventive Actions (CAPAs). Proficiency in statistical analysis and Design of Experiments (DOE) methodologies. Ability to apply engineering principles to solve technical issues in a production environment. Requirements Master’s degree or Bachelor’s degree in Engineering & 2 years of Engineering experience Fully Bilingual (English & Spanish) Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays. Shift: 1st or 2nd
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
