Principal Engineer 35424

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.

• 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.

1. Working knowledge of pharmaceutical/biotech processes.

2. Familiarity with validation processes and documentation in a highly regulated environment.

3. Establish engineering policies for a major segment of the company.

4. Interpret, execute, and recommend modifications to company-wide policies.

5. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project.

6. Ability to interpret and apply GLPs and GMPs.

7. Able to develop solutions to routine technical problems of limited scope

8. Demonstrated skills in the following areas of problem solving and applied engineering. Technical report writing and verbal communication in English.

9. Comprehensive understanding of validation protocol execution requirements.

Doctorate + 2 years Engineering experience OR Masters + 4 years of Engineering experience OR Bachelors in Engineering + 6 years of Engineering experience.