Job Title: Computer System Validation Specialist
This is a highly specialized role that requires experience with computer system validation in the pharmaceutical industry.
The successful candidate will be integrally involved in the validation of all new computerized equipment and control systems, generating validation documentation and providing assistance with protocol execution.
They will participate in the change control process, advising on CSV issues, and ensure projects are managed in compliance with all required regulations.
The ideal candidate will have a degree in Science or Engineering, preferably in Chemistry, Microbiology, or Pharmacy, and 3-5 years of experience working in a healthcare manufacturing environment, ideally in the pharmaceutical sector.
Key responsibilities include designing, implementing, and executing validation studies for manufacturing and control equipment, providing technical assistance on current US FDA and EU validation requirements, and ensuring the validation status of equipment and systems complies with cGMP at all times.
* Develop and execute validation protocols for computerized equipment and systems.
* Generate and review validation reports and documents.
* Participate in change control processes and advise on CSV issues.
* Ensure compliance with cGMP, Health & Safety, and regulatory requirements.
* Provide technical assistance on validation requirements.