Validation Engineer

Team Horizon is seeking a Validation Engineer for our client’s Technical Operations team in the Northwest. This is a fixed term contract for 12 months and will report to the Validation Team Lead.

• This role is a fully on-site position in Ireland, are you willing to relocate?
• Do you have authorisation to work in the EU?

Why you should apply:

• This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you
• 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.
   

What you will be doing:

• 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.

What you need to apply:

• 3rd level qualification in a relevant engineering or scientific discipline.
• A minimum of 2 years’ experience in a cGMP regulated pharmaceutical manufacturing environment.
• High level of attention to detail and mental concentration, to ensure accuracy and compliance. Excellent communications skills with the ability to write protocols and reports. 
• Proven problem-solving skills and the ability to adapt to new regulatory requirements.

• This role is a fully on-site position in Ireland, are you willing to relocate?
• Do you have authorisation to work in the EU?