Senior Validation Engineer

7 days ago


Sligo, Sligo, Ireland Team Horizon Remote Work Freelance Full time
Job Description:

We are seeking an experienced Validation Engineer for a 12-month contract to join our team at Team Horizon's manufacturing facility in Sligo.

The ideal candidate will have a strong understanding of regulatory requirements and experience in ensuring compliance with Data Integrity policies and standards. Key responsibilities include:

• Coordinating and participating in the validation of site equipment, facilities, utilities, processes, and software;
• Developing and maintaining Validation Master Plans and Project Validation Plans;
• Generating validation plans, protocols, and final reports to cGMP standard;
• Reviewing and approving all protocols and final reports;
• Managing the validation change control process;

The successful candidate will be able to work effectively in a fast-paced environment and have excellent communication skills. In addition, they should have a good understanding of ASTM E risk-based qualification and critical process parameters/non-critical process parameters.

A minimum of 5-10 years' experience in a cGMP regulated environment is required, along with a 3rd level qualification in a relevant engineering or scientific discipline. Experience in process validation (PPQ) in API or drug product, managing validation events/non-conformances during PPQ FUE qualification, and working with Engineering and other stakeholders to understand validation requirements are essential.

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