Principal Engineer

Ultimate Solutions•Juncos, PR

About The Position

Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For over 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical, biotechnology, medical device, and logistics sectors. Description: The Principal Engineer 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.

Requirements

Doctorate degree and 2 years of Engineering experience OR Master’s degree and 4 years of Engineering experience OR Bachelor’s degree in Engineering and 6 years of directly related experience.
Mechanical or Chemical Engineer, preferred.

Nice To Haves

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.
Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas: Problem solving and applied engineering.
Basic technical report writingo Verbal communication
Comprehensive understanding of validation protocol execution requirements.

Responsibilities

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.