Csv Engineer
The role of the Csv Engineer is crucial in ensuring ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.
* Key responsibilities include:
* Integrally involved in the validation of all new computerised equipment and control systems
* Generates validation documentation (protocols/reports) and provides assistance with protocol execution
* Participates in change control process, advising on Csv issues as appropriate
Validation Responsibilities
* Hands-on role in DQ, IQ, OQ, and PQ activities development and execution
* Ensures projects are managed in compliance with required legal requirements (Health & Safety, cGMP, construction, environmental etc)
* Designs, implements, and executes validation studies for manufacturing and control equipment
Compliance Related Tasks
* Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation
* Ensure validation status of equipment and systems is compliant with cGMP at all times
* Maintain validation documentation through approval and implementation of changes to relevant systems
Additional Responsibilities
* Ensuring quality standards are upheld in production processes
* Liaising with cross-functional teams to implement validation strategies
* Developing and maintaining complex validation documents