Sr. Engineering

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