Validation Engineer
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is seeking a highly skilled Validation Engineer to join their state-of-the-art pharmaceutical facility. This esteemed role offers an unparalleled opportunity to be part of a world-class team driving innovation and excellence in the industry.
About the Role:
* Ensure all Computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Coordinate and actively participate in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
* Generate and maintain Validation Master Plans.
* Develop and implement Project Validation Plans.
* Create validation plans, protocols, and final reports to cGMP standard.
* Review and approve all protocols and final reports.
* Manage the validation change control process.
* Adhere to and support all EHS & E standards, procedures, and policies.
Requirements:
* Hold a 3rd level qualification in a relevant engineering or scientific discipline.
* Possess a minimum of 5-10 years' experience in a cGMP regulated environment.
* Have a good understanding of regulatory requirements.
* Demonstrate high attention to detail and mental concentration to ensure accuracy and total compliance with procedures at all times.
* Exhibit proven problem-solving skills and adaptability to new regulatory requirements.
* Showcase innovative thinking, proposing, demonstrating, and implementing new and untested solutions regularly.
About Our Client:
Our client is a reputable global pharmaceutical leader, renowned for its commitment to quality, safety, and innovation. Their cutting-edge pharmaceutical facility is located in the historic province of Connacht, amidst a unique blend of Irish culture and modernisation.