QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA Responsibilities: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. Application of mature engineering knowledge in planning and conducting projects. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications. Qualifications: Bachelor's degree in Chemical/Biochemical, Engineer or other biological engineering/sciences 5 years of Engineering experience Ongoing manufacturing support, including troubleshooting, nonconformance resolution, and process monitoring using Statistical Process Control methodologies Process modeling to guide development activities, identify process implementation issues and drive optimization Good written and verbal communication skills. Knowledge engineering principles, methods and practices. Knowledge of biotechnology unit operations and process equipment. Understanding of cGMPs as applied to biotechnology products. Knowledge in product filling process, including Laboratory testing's, component preparation process, Formulation Process and vial or syringe filling. Process characterization, process validation and process monitoring experience. Basic working knowledge of Process equipment design and evaluation expertise. Knowledge of statistical analysis of data and design of experiment (DOE) approaches. Shift: 8hrs | 8:00am to 5:00pm Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR
