Validation Senior Analyst

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 Nonconformance (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 Nonconformance (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

• Bachelor of Science Degree in relevant field (science, engineering, etc.)
• 5-7 years related experience or equivalent combination of education and experience