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Senior Validation Specialist
2 weeks ago
We are seeking an experienced Validation Engineer to join our team in County Sligo, Ireland. Located on the picturesque west coast of Ireland, this is a fantastic opportunity to work for a global pharmaceutical client.
This role offers a 6-month contract with the possibility of extension. The successful candidate will be responsible for ensuring all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
The Validation Engineer will coordinate, direct, and actively participate in the validation of site equipment, facilities, utilities, processes, and software in accordance with company policies, FDA, European cGMP, and GAMP standards.
Key Responsibilities:
- Ensure compliance with regulatory requirements
- Coordinate validation activities
- Generate and maintain validation plans and protocols
- Review and approve validation reports
- Manage change control process
Requirements:
- Third-level qualification in engineering or scientific discipline
- Minimum 5-10 years' experience in cGMP regulated environment
- Strong understanding of regulatory requirements
- High level of attention to detail and concentration
- Proven problem-solving skills and adaptability