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 provide support to the transfer of a catheter with robotics product from California to Costa Rica. Also support validation activities at Costa Rica when required. Relocation to California for the length of the project is required. Experience in regulated environment industries such as medical device is preferred. 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 preferred
- Project Management knowledge.
- Fully Bilingual (English/Spanish)