Quality Engineer - Spark Life Solutions Inc
North Carolina, NC 75074
About the Job
Key Responsibilities:
- Implement and drive process improvements to ensure product quality and manufacturing efficiency.
- Conduct thorough investigations and document findings related to product quality issues, utilizing strong technical writing skills.
- Ensure the validation and maintenance of Filling Equipment,Packaging Equipment, and Automation/Control Systems.
- Oversee and validate Process Compressed Gas systems, HVAC systems for controlled environments, and monitor subsequent performance.
- Manage the validation and monitoring of compendia water purification systems.
- Maintain a solid understanding of microbiology to assess potential contamination sources, ensuring compliance with sterilization and contamination control measures.
- Provide expertise in terminal sterilization processes and pest control management to maintain optimal manufacturing conditions.
- Bachelor's degree in Engineering is preferred. Degrees in Engineering Technology, Biology, Microbiology, or Chemistry may be considered based on relevant experience.
- Minimum of 6 years of experience in a regulated manufacturing environment, preferably within the pharmaceutical or medical device industry.
- Familiarity with regulatory requirements related to manufacturing quality systems.
- In-depth knowledge of microbiology, contamination control, and sterilization processes.
- Strong problem-solving, investigation, and analytical skills with a focus on continuous improvement.
- Previous experience with IV solutions and IV bag manufacturing is highly desirable.
- Knowledge of automated control systems, HVAC, gas systems, and water purification systems.
- Understanding of controlled environments, terminal sterilization, and pest control protocols.
- Strong verbal and written communication skills.
- Ability to work in cross-functional teams and lead quality improvement initiatives.
- Adept at working in fast-paced environments with a focus on safety and compliance.
Source : Spark Life Solutions Inc