Sr. Validation Analyst

Responsible for the validation of IT systems.General Functions –§ Serves as a liaison between Quality Systems and IT for the purposes of Software Validation.§ Serves as a “hands-on” Validation Lead for:o Software development and enhancement projects. o Validation of legacy system projects o Validation of changes to existing processes and systems§ In consultation with IT and business personnel writes software validation documentation.§ First priority is to work on validation for systems that are managed by the Information Technology department. Will also perform validation work for other applications utilized throughout Zimmer. § Work with Change Control Analyst and other IT resources to research and utilize existing validation protocols to keep validated systems in a validated state.§ Manages, controls, and files validation documentation up to the point of turnover to the Document Control Department § Interacts with Change Control Analyst and Quality Systems to coordinate validation work and share validation tools and techniques. § Performs all validation work in compliance with Zimmer Policies and Procedures, as determined by Quality Systems§ Serves as a backup to the Change Control Analyst for running the CCB meetings and the administration of change control tickets.This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADAExpected Areas of Competence (i.e. KSAs) –§ Ability to communicate in a clear, concise manner including previous experience in writing technical documentation.§ Able to work in a team environment.§ Possess strong organizational and interpersonal skills.Education Requirements – B.S. degree in a relevant field or equivalent work experience is required. Skill Requirements – Experience in writing FDA software validation protocols. Broad general understanding of information technology applications and hardware. Proven ability to write technical documentation. Proven ability to write software requirements and tests. Able to review the work of others and to provide constructive criticism. Able to lead and prioritize tasks and to drive projects to completion. Licenses/Certifications – None.Travel Requirements – 5% - 10% Education: BachelorsJob Level: 3 - 5 yearsPercent Travel: 1-10%