Our client is currently in the process of starting up a clinical cell therapy site with clean rooms.
They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies.
The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and commissioning processes.
They are currently needing a Sr. Validation Engineer to come in and help review the commissioning plan and validating the documentation.
They will then begin the commissioning execution for all utilities, facilities and some computer systems.
The systems they can expect to be working with are liquid systems, air handling, compressed air, batch record systems and Client and EMS.
Develop and Review Validation Protocols.
Create and review IQ, OQ, PQ protocols for utilities and facility systems.
Ensure protocols meet regulatory requirements.
Execute IQ, OQ, and PQ testing on utilities and facility systems
Validate the installation, operation, and performance of critical equipment.
Conduct FAT and SAT for utilities and equipment.
Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment.
Verify equipment performance against specified requirements.
Validate cleanroom conditions.
Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments.
Write technical reports on commissioning, qualification, and validation activities
Implement change control procedures for modifications to utilities and facility systems during commissioning.
Ensure proper documentation of any system changes, including impact assessments.
Collaborate with Engineering and Operations Teams:
Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested.
Provide guidance to operations teams on system startup and maintenance procedures.
Compliance and Regulatory Review:
Ensure all validation and commissioning work complies with regulatory guidelines and internal GMP requirement.
Requirements
8+ years of experience as a Validation Engineer to include:
Experience with full life cycle of validation activities for facilities and utilities systems
Experience with validation activities for clean rooms including