Validation Engineer III
About The Position
At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We are currently recruiting for a Validation Engineer III to join our Engineering Team. In this role, you will support Engineering, Manufacturing, Quality Control, and Facilities teams by executing initial validation and qualification of equipment, utilities, facilities, and systems, as well as implementing the requalification and periodic review program. You will play a key role in advancing our mission and making a meaningful difference.
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
Responsibilities
- Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
