Principal Engineer (Clean Utilities)

Job Description

Job Description

SUMMARY
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.

FUNCTIONS
1. Establish engineering policies for a major segment of the company.
2. Interpret, execute, and recommend modifications to company-wide policies.
3. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.
4. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts.
5. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
6. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
7. Plan, organize and coordinate work of a staff of engineers and/or technicians.
8. 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.
9. Established a corporate Engineering resource, specializing in more than one area of engineering.
10. Designs, executes, implements, and directs engineering or process projects which significantly contribute to attaining high-priority goals.** Other functions may be assigned.

EDUCATION
-Doctorate + 2 years Engineering experience OR
-Master’s + 4 years of Engineering experience OR
-Bachelor's in engineering + 6 years of Engineering experience.

PREFERRED QUALIFICATIONS

1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope
8. Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing o Verbal communication
9. Comprehensive understanding of validation protocol execution requirements.

 

What attributes (i.e. - preferred qualifications) would make this candidate stand out?   

Preferred: Experience with Clean Utilities and GMP investigation, Deviation Documentation