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Validation Specialist II
2 months ago
This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities, and computer systems utilized in the manufacture of product are validated for intended use.
Key Responsibilities- Develop and execute validation strategies, timelines, and resource requirements for new and existing facilities, utilities, and equipment.
- Coordinate and communicate validation tasks, including the development of validation test protocols and reports.
- Operate instrumentation to perform environmental monitoring studies.
- Review and approve documents, including User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests.
- Author documents related to data integrity and system administration.
- Participate in audit interviews and support audits performed by regulatory agencies.
- BS in Engineering, Chemistry, Microbiology, or related field.
- Desirable cGxP validation experience, including data integrity, installation qualification, operational qualification, and performance qualification.
- Experience with investigations and root cause analysis principles.
- Excellent technical writing and verbal communication skills.
- Demonstrated ability to manage complex validation projects in a fast-paced environment.
We offer diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements, and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. We respect your privacy and any use of the information submitted will be subject to the terms of our privacy policy.
