We are looking for a Validation Engineer to join our Technical Operations team in Manorhamilton Road, Sligo. This is a fixed term contract for 12 months. This position reports to the Validations Team Lead. This role provides the successful candidate with the opportunity to get exposure to a broad range of validation activities on our site. You will be responsible for co-ordinating the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.

Responsibilities:

• Co-ordinate, implement and participate in the site Validation Program.
• Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
• Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generate/maintain Validation Master Plans.
• Generate /maintain Project Validation Plans.
• Generate validation plans, write protocols and final reports to cGMP standard.
• Review / approve of protocols and final reports as required.
• Manage validation change control process.
• Adhere to and support all EHS & E standards, procedures and policies.