Inteldot has over 15 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative shift: Office hour but not limited, ability to work _on weekend or night (hybrid)
Job Description:
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.
Must Have:
- 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.
Qualifications:
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.
Education:
Doctorate + 2 years Engineering experience OR Masters + 4 years of Engineering experience OR Bachelors in Engineering + 6 years of Engineering experience.
Skills Required
- Experience working with clean utilities systems (Distilled Water, Purified Water, RO systems)
- Experience working with clean gases (Process Air, GMP gases such as Oxygen and Nitrogen)
- Experience documenting and managing deviations (non-conformance)
- Proficiency in GMP documentation and SOP process improvement
- Ability to work in critical operations and capital project environments
- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes and documentation in a regulated environment
- Ability to interpret and apply GLPs and GMPs
- Comprehensive understanding of validation protocol execution requirements
- Education: Doctorate +2 years OR Masters +4 years OR Bachelors +6 years engineering experience
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
