Senior Validation Specialist
3 days ago
This is a specialized coordination role that involves managing and maintaining site validation programs for clients. The ideal candidate will be responsible for ensuring compliance with regulatory, quality, and compliance requirements.
Key Responsibilities:- Coordinate the validation of equipment, utilities, processes, and software to ensure alignment with client policies, FDA, European cGMP, and GAMP standards.
- Develop project validation plans and schedules.
- Design and implement validation protocols and final reports in line with cGMP standards.
- Investigate and implement corrective actions related to validation.
- Manage and track validation processes, exception events, and change control.
- A minimum of 2 years' experience in validation engineering, preferably in medical device plastics processing, molding, or assembly operations.
- Proven knowledge of cGMP and regulatory requirements in the medical device industry.
- Strong documentation and review skills.
- Experience in developing and maintaining a site validation master plan in the Medical Devices or Life Sciences manufacturing sector.
This is an exciting opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry-leading technology solutions.
Our company offers a supportive environment committed to employee development and wellness, along with a competitive compensation package that rewards high performers.
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Sligo, Sligo, Ireland beBeeSiteValidation Full time €55,000 - €85,000Job Overview">We are seeking a highly skilled Site Validation Specialist to join our team. In this role, you will be responsible for coordinating the development and maintenance of site validation programs.The ideal candidate will have experience in ensuring compliance with regulatory, quality, and compliance requirements.Key Responsibilities:">Validate site...
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