Validation Engineer III
Durham, North Carolina, United States of America
Full Time
3 days ago
Visa Sponsor
Key skills
Risk Management
About this role
Role Overview
- Write, execute, summarize and lead validation activities for analytical instruments, computer systems, equipment, utilities, and facilities
- Development of validation plans and validation plan summary reports
- Develop, review, and provide guidance on internal validation documents
- Develop, support, and assess CAPAs, change controls, deviations, investigations and risk management as they pertain to validation
- Provide technical input to strategy/philosophy for validation activities
- Represent validation during tech transfer activities
- Front facing during agency inspections and client audits representing the validation function
- Lead and manage complex validation and technical projects
- Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support
Requirements
- Minimum of bachelor’s degree in science, engineering or related discipline
- 5+ years of experience in the execution of validation studies in a regulated manufacturing environment
- Thorough knowledge and understanding of FDA and international health authority expectations
- Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs
- This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities