The Role
Supports packaging equipment and production processes in a GMP-regulated environment. Responsibilities include process characterization, validation, monitoring, optimization, CAPA management, technical report writing, statistical analysis, DOE, root cause investigations, and resolving production issues. Requires flexibility to work first- or second-shift schedules, including nights, weekends, holidays, and extended hours.
Summary Generated by Built In
We are seeking an Engineer with experience working with packaging equipment, process characterization, validation, monitoring, and optimization techniques and Expertise in identifying and managing Corrective and Preventive Actions (CAPAs), in a GMP-regulated environment .
- Proficiency in technical report writing.
- Strong problem-solving skills and experience conducting root cause investigations.
- Proficiency in statistical analysis and Design of Experiments (DOE) methodologies.
- Ability to apply engineering principles to solve technical issues in a production environment.
- Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays.
- Shift: 1st or 2nd
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
Skills Required
- Bachelor's or Master's degree in Engineering
- At least 2 years of engineering experience
- Fully bilingual in English and Spanish
- Experience with packaging equipment
- Experience with process characterization, validation, monitoring, and optimization
- Experience identifying and managing Corrective and Preventive Actions (CAPAs) in a GMP-regulated environment
- Technical report writing proficiency
- Strong problem-solving and root cause investigation skills
- Proficiency in statistical analysis and Design of Experiments methodologies
- Availability for non-standard shifts, extended hours, nights, weekends, and holidays
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
