Validation Engineer III
Durham, North Carolina, United States of America
Full Time
1 hour 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 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
- A company that lives its values: Responsible, Responsive, Resilient, Respect