Overview
In this role, you will be responsible for leading investigations into Engineering and Validation deviations. You will apply process, quality, compliance, and analytical knowledge to:
1. Triage Non-conformances within established goals and serve as a deviation owner for minor and major deviations.
2. Initiate and manage deviation investigations, including establishing investigation teams, conducting root cause analysis, developing CAPAs and EVs, completing product impact assessments, reviewing prior occurrences, and authoring investigation reports.
3. Own corrective and preventative actions and verify their effectiveness.
4. Update and maintain F&E procedures in accordance with site and corporate requirements. Serve as a document owner, assist in generating training materials, and provide training on scientific or technical aspects of the process.
5. Present investigations to regulatory inspectors and internal auditors. Provide support during on-site regulatory inspections.
6. Oversee F&E audit readiness activities and track tasks to completion. Represent the F&E function at Site Inspection Steering Committee meetings.
7. Generate Quality and Safety metrics for the F&E function and report on quality and safety compliance.
8. Participate in multidisciplinary site and multisite teams, such as improvement initiatives, compliance topics, and change control GDEs.
9. Assist with generating and executing validation protocols and reports.
Requirements
A Bachelor's degree in Biology, Life Science, or Engineering, or an equivalent combination of education and experience.
Experience
At least 3 years' experience in a similar role.
Competencies/Skills
1. Detailed understanding of manufacturing and engineering unit operations.
2. Skilled in performing GMP production operations.
3. Regulatory knowledge and interactions.
4. Ability to lead cross-functional teams.
5. Ability to communicate and collaborate with technical and management staff.
6. Excellent organizational, technical writing, and presentation skills.
7. Good project management skills.
8. Basic knowledge of control charting.