Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
The Validation Engineer will be in charge of the documentation development and execution for serialization equipment validation. The client requested at least 2 weeks on site at North Carolina during project initiation validation strategy definition; then the resource can work remotely for the documentation development period. Also, during the execution process, that may take around 8 weeks, it is required to be on site. Experience in serialization and Systech systems, Generates, executes, reviews, and complete qualification and validation documentation, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Bachelor's Degree in engineering or science and 3 years of experience.
Ultimate Solutions Corp is an equal opportunity employer.
- A solid understanding of FDA Validation guidelines
- GMP and regulatory experience with expertise in process validations.
- Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ).
- Experience in writing SOP’s
- Experience with Technical Writing and Kneat knowledge preferred
- Fully Bilingual (English/Spanish)