The Validation Engineer/Specialist will provide support to the engineering and quality department in the validation of products, equipment or process in the manufacturing and packaging areas. Also support pro-field executions and must have availability to work in different shifts. The successful candidate must have Validation experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies. 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 Degree in Engineering or Science and 3 years or more 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.
- Statistical knowledge, DOE and Quality Process Control experience is preferred.
- Project Management knowledge.
- Fully Bilingual (English/Spanish)