Validation Engineer - County Sligo, Ireland
A global pharmaceutical client seeks a Validation Engineer to join their state-of-the-art facility in the picturesque west coast of Ireland.
Responsibilities:
* Qualify computerized systems in compliance with data integrity policies and regulatory requirements.
* Coordinate validation activities for site equipment, facilities, utilities, processes, and software according to company policies, FDA, European cGMP, and GAMP standards.
* Develop and maintain validation master plans.
* Create project validation plans.
* Generate validation plans, protocols, and final reports to cGMP standard.
* Review and approve protocols and final reports.
* Manage the validation change control process.
* Maintain adherence to EHS and E standards, procedures, and policies.
Requirements:
* Bachelor's degree in a relevant engineering or scientific discipline.
* At least 5-10 years of experience in a cGMP-regulated environment.
* Familiarity with regulatory requirements.
* High attention to detail and mental concentration to ensure accuracy and total compliance with procedures.
* Proven problem-solving skills and ability to adapt to new regulatory requirements.
* Innovative thinking to propose, demonstrate, and implement new solutions regularly.