Validation Specialist

This position will be for a Validation resource for Computerized Systems validation. The candidate should have a clear understanding of the Validation life cycle as well as experience with software validation. MRP, CMMS,  Documentum and system interface experience would also be a plus.

Job Description:

·    BS Degree with experience in computer and application validation, cGMP’s, and 21 CFR Part11 in a FDA regulated environment.
·    Responsible for creating all validation documentation.
·    Oversees execution of all protocols.
·    Writes final validation reports.
·    Reconciles all deviations.
·    Minimum of four years relevant compliance experience in the Pharmaceutical industry.
·    Working experience with databases, applications and personal computers with windows operating systems and networking is required.
·    Knowledge of validation principals, including system development life cycle methodology is required.
·    Excellent written and verbal communication skills.
·    Good Problem solving and project management skills.
·    Ability to work on multiple projects.
·    Proficient computer skills and Microsoft word required.
·    Documentum experience is a plus.