Principal Engineer 35423
Remote · Juncos, Juncos, Puerto Rico
Job Summary
Principal Engineer role overseeing complex, non-routine projects in life sciences facilities, coordinating design, reconfiguration, construction, maintenance and alteration of systems and processes. Requires extensive technical expertise across multiple engineering areas (process, unit operations, equipment) for process characterization, optimization, scale-up, or manufacturing support. Must have hands-on experience with clean utilities and GMP/GxP documentation, deviation management, and SOP/process improvement, with the ability to lead engineering policy development, budgeting for large projects, and interpretation/application of GLPs/GMPs. Education path includes Doctorate with engineering experience or Masters/Bachelors with significant experience. Remote work option indicated; location in Juncos, Puerto Rico with potential for weekend/night work and hybrid schedule.
Required Qualifications
- 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 and documentation in a highly regulated environment
- 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
- Ability to interpret and apply GLPs and GMPs
- Able to develop solutions to routine technical problems of limited scope
- Demonstrated skills in technical report writing and verbal communication in English
- Comprehensive understanding of validation protocol execution requirements
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