CV-Library
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?
£43300 – £56300/annum Bonus, Pension, Healthcare