Validation Engineer Role
In this role, you will be responsible for ensuring all computerized systems are qualified in compliance with data integrity policies and regulatory requirements.
* Ensure all Computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Coordination/direction and active participation in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
* Generation/maintenance of the Validation Master Plans.
* Generation/maintenance of Project Validation Plans.
* Generation of validation plans, protocols, and final reports to cGMP standard.
* Review/approval of all protocols and final reports.
* Management of validation change control process.
Requirements
* Third-level qualification in a relevant engineering or scientific discipline.
* A minimum of 5-10 years' experience in a cGMP regulated environment.
* A good understanding of regulatory requirements.
* Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
* Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
* Requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented on a regular basis.