JT104 - PRINCIPAL ENGINEER at Quality Consulting Group – Juncos

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.
• Establish engineering policies for a major segment of the company.
• Interpret, execute, and recommend modifications to company-wide policies.
• Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.
• Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
• Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
• Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
• Plan, organize and coordinate work of a staff of engineers and/or technicians.
• 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.
• Established a corporate Engineering resource, specializing in more than one area of engineering.
• Designs, executes, implements and directs engineering or process projects which significantly contribute to attaining high priority goals.** Other functions may be assigned.

Qualifications:

• Bachelor’s degree in engineering (Mechanical or Chemical Engineering preferred)
• 6+ years of Engineering experience
• Experience Working with Clean Utilities Systems such as Distilled Water, Purified Water, RO System.
• Experience working on Clean Gases [Process Air, GMP gases supply like Oxygen, Nitrogen]
• Experience documenting and managing Deviation [non-conformance]
• Proficient in GMP documentation and the process improvement of SOP documents.
• Ability to work on Critical Operation and Capital project environment.
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Administrative shift but not limited, ability to work on weekend or night

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.