8705 Validation Engineer I
Execute equipment qualification testing (IQ, OQ, and PQ) and generate related documentation (e.g. protocols, reports).
Work with supervisor/ manager and system owners to maintain schedule and resolve issues.
Ability to lead teams composed of validation professionals and, to perform analysis of current business processes to translate development documents into user requirements, and functional design specifications.
Experience authoring Validation Plans, IQ, OQ & PQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports for assigned projects.
Experience in authoring protocol deviation documentation and in their resolution and final disposition. Outstanding communication skills, both verbal and written.
Ability to engage, interact, and negotiate effectively with project team members.
5-8 years experience with Validation/Qualification.
Proficient in use of all Microsoft Office solutions.
Minimum requirement is a Bachelors degree Science or Engineering.