Validation Engineer
Full-timeMidR&D and ValidationOncologyBachelors
Description
The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution. Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary.
Requirements
B.S. in science/engineering field and 1 to 2 years of equipment qualification/validation experience. Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs). Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines. Hands-on experience with Kaye validator and temperature mapping.
Pipeline
Leukocyte Interleukin, Injection 200IUPhase 1
Leukocyte Interleukin, InjectionPhase 1
LIPhase 3