About the job
We are seeking a skilled Computer System Validation Specialist to join our team. The successful candidate will be responsible for developing User Requirement Specifications (URS), managing Document Change Approvals (DCA), and conducting impact assessments for engineering and computer system validation. Key responsibilities include:
- Managing DCA processes, including document numbering, uploads, and routing for approval.
- Performing Systems Impact Assessments, distinguishing between engineering and CSV impacts.
- Entering data and managing spare parts within Maximo CMMS, including instruments for temperature/humidity, calibration forms, and job plans for electrical and mechanical equipment.
- Developing commissioning protocols, performing testing, and preparing reports for approval.
- Creating Risk Assessments and Validation Plans, ensuring all documents undergo a structured review process.
- Managing the installation and data collection from temperature and humidity data loggers.
- Contributing to the development and execution of Turn Over Packages (TOP) and Standard Operating Procedures (SOPs).
