Overview
On Site
Full Time
Skills
Expect
Element Management System
EMS
IQ
OQ
PQ
Testing
Change Control
Documentation
Collaboration
Startups
Regulatory Compliance
GMP
Adobe AIR
Visualization
Computerized System Validation
SAP
Job Details
Responsibilities:
Requirements:
- 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
- Cell counters, freezers, air handlers, compressed air, aseptic systems, smoke studies (Air flow visualization studies), Lab systems.
- Experience validating CSV systems including EVR, SAP, Client
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.