Overview:

In this role, you will be responsible for leading investigations for Engineering and Validation deviations, along with being involved in applying process, quality, compliance, and analytical knowledge to complete the following:

• Ensure Non-conformance are triaged within the established goals and serve as a deviation owner for minor and major deviations.
• Initiates and manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs and EV’s, completing product impact assessments, prior occurrence reviews and authoring investigation reports.
• Own corrective /preventative actions and effectiveness verification.
• Update and maintain F&E procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Present investigations to regulatory inspectors and internal auditors. Provide back-room support during on-site regulatory inspections.
• Oversee F&E audit readiness activities and track tasks to completion. Represent F&E function at Site Inspection Steering Committee meetings.
• Generate Quality and Safety metrics for F&E function. Provide reports on quality and safety compliance.
• Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. improvements, compliance topics and change control GDEs
• Assist with generation and execution validation protocols and reports.
  
  

EDUCATION

B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.

Experience

3+ years' experience in a similar role

Competencies/Skills

• Detailed technical understanding of manufacturing/engineering unit operations.
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Ability to lead cross-functional teams
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Excellent organizational, technical writing and presentation skills.
• Good project management skills.
• Basic knowledge of control charting.