Senior Biological Systems Validator

1 week ago

Singapore beBeeValidation Full time

Our organization specializes in emerging and frontier biology.

We utilize cells as a final product or derive products from cells which often we use cells as the factory to derive our target product.

Our team contributes to the overall site mission and objectives by ensuring Commissioning Qualification and Validation activities are planned and executed efficiently and compliantly, adhering to industry standards.

You will work with cross-functional departments to develop a continuous improvement mindset.

  • Perform risk-based commissioning, qualification, and validation of equipment, utilities, facilities, and processes.
  • Develop protocols and reports that fulfill regulatory requirements and industry best practices.
  • Assist in developing User Requirements Specification documents.
  • Prepare design review and design qualification documents at the initial design stage to align with specifications.
  • Generate protocols and execute field work related to Installation & Operational Qualification (IOQ).
  • Prepare and execute validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation, and Transport Qualification.
  • Complete assigned tasks according to planned schedule, budget, safety, and engineering standards.
  • Coordinate with internal teams to achieve objectives.
  • Investigate deviations and write deviation reports and findings.

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