Job Title: Validation Engineer
Our client is at the forefront of immunotherapy and engineered T cell therapy, revolutionizing cancer treatment and revolutionizing personalized therapies. They thrive in a dynamic and constantly evolving environment, where groundbreaking discoveries are made on a daily basis.
We are seeking a highly motivated individual to join our team as a Validation Specialist. In this role, you will be responsible for conducting routine validation activities and providing support for validation projects. Your main responsibilities will include creating and executing commissioning, qualification, and validation protocols, performing temperature mapping, investigating, and resolving exceptional conditions, and coordinating validation instrument inventory calibrations. Additionally, you will collaborate with Quality Engineering to develop Computerized System Validation (CSV) strategies and procedures.
- Develop and execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), ensuring the identification and resolution of exceptional conditions.
- Conduct temperature mapping and various other validation activities.
- Investigate and implement corrective actions for protocol Exceptional Conditions.
- Coordinate validation instrument inventory calibrations and certifications.
- Support vendor protocol executions as required.
- Create CSV documents, including Risk Assessments, Validation Project Plans, User Acceptance Tests, and Reports.
- Collaborate with Quality Engineering to establish CSV strategies and procedures.
- Provide guidance and execute commissioning and qualification for computerized systems, equipment, utility systems, and facilities during project planning and development phases.
- Review technical documentation, including protocols, summary reports, and SOPs for CSV and Commissioning, Qualification & Validation (CQV) lifecycle documentation.
- Regularly report the status and progress of qualification activities or projects to the Leadership team.
- Investigate and implement corrective actions for CAPAs and deviations.
- Manage contractors involved in equipment and system commissioning, qualifications, and validation.
- Develop or review technical specification documents required for the generation and execution of CQV lifecycle documentation.
- Perform additional duties as assigned, which may be delegated to qualified deputies.
- Minimum of a Level 4 MBO diploma with at least 6 years of experience or an HBO degree with at least 4 years of experience.
- Experience in a GMP environment within the pharmaceutical or relevant industries.
- Strong background in validation procedures.
Are you ready to take a new step in your career? If you are interested or know someone who is interested, please contact and upload your resume using the apply button.
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