Senior Validation Analyst
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Job Description
Job Summary
Responsible for ensuring that equipment, process and analytical methods are validated. Support production by providing ongoing quality engineering support throughout the product life cycle and perform Non Conformance (NC) and Out Of Specification (OOS) investigations.
Principal Duties and Responsibilities
Review and execute Installation (IQ), Operation (OQ) and Performance Qualification (PQ), test method validation protocols (TMV) and analytical test methods.
Provide guidance/direction to teams upon review of validation documentation.
Serve as a "hands-on Validation Lead for Validation of changes to existing processes, systems and equipment.
Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer's specifications, operational procedures, calibration requirements and required maintenance.
Perform Non Conformance (NC) and Out Of Specification (OOS) investigations.
Analyze processes and methods related to quality improvement (e.g. Six Sigma, statistical tools, etc.), product and process risk management (PFMEA) and corrective and preventive action (CAPA).
Assist with audits, explaining validation and qualification activities performed at the site.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
Proven ability to write technical documentation
Proven ability to write analytical methods requirements and tests
Able to lead and prioritize tasks and to drive projects to completion
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/Experience Requirements
Bachelor of Science Degree in relevant field (science, engineering, etc.)
5-7 years related experience or equivalent combination of education and experience
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.