Job Description
A highly skilled Computer Systems Validation Engineer is required to validate new computerised equipment and control systems.
* Generate validation documentation (protocols/reports)
* Provide assistance with protocol execution for computerised equipment and systems
* Participate in change control processes, advising on CSV issues as appropriate
The role involves design, implementation, and execution of validation studies for manufacturing and control equipment. The engineer will ensure projects are managed in compliance with all required regulations.
Key Responsibilities
1. Design and implement validation studies for manufacturing and control equipment
2. Execute validation studies and ensure compliance with regulatory requirements
3. Participate in the change control process and advise on CSV issues
4. Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation
5. Maintain validation documentation through the approval and implementation of changes to relevant systems
The ideal candidate will have excellent communication skills and be able to work effectively in a team environment. They will also have strong problem-solving skills and be able to prioritize tasks effectively.