Principal Engineer

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:

• Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes. 
• Employs an extensive technical knowledge of more than one area of engineering (process, unit operations, and equipment project) in complex process characterization, optimization, scale-up, or manufacturing support projects. 
• Interpret, execute, and recommend modifications to company-wide policies.
• Knowledge of validation processes and requirements as applied to new equipment installations.
• Develop organizational budgets or project budgets encompassing all disciplines for large or complex projects. 
• Lead efforts 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 or process modifications. 

Qualifications:

• Bachelor's degree in Engineering
• Eight (8) years of previous experience
• Multiple years of experience in filling process validation, characterization or commercial support.
• Experience in Process Characterization and Data analysis.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Availability to support non-standards shift that may include extended and/or weekend shifts as per business needs.