Equipment Validation Specialist
4 days ago
As a key member of our team, you will be responsible for providing quality oversight for validation, qualification, and replacement of manufacturing process equipment.
You will assess and approve acceptance tests, reports, and documentation in line with policies and compliance requirements. Additionally, you will review and authorize engineering changes, deviations, and exceptions during validation activities.
Your role will involve working closely with multidisciplinary teams to plan, coordinate, and execute validation procedures efficiently. You will also support technical modifications and undertake additional validation-related duties as assigned.
In this position, you will maintain compliance with cGMP standards while ensuring adherence to site safety and security regulations. Furthermore, you will act as a liaison with stakeholders to ensure proper implementation of validation processes.
Finally, you will oversee work area maintenance, ensuring cleanliness and organization during and after validation tasks.
About You- At least 5 years of experience in equipment validation within a GMP-regulated environment.
- A Bachelor's degree in Engineering, Life Sciences, or a related field is preferred.
- Strong knowledge of cGMP standards and regulatory compliance for equipment validation.
- Experience in reviewing and approving validation protocols, deviations, and change requests.
- Ability to lead and coordinate validation activities across multiple projects.
- Excellent problem-solving skills and keen attention to detail.
- Strong interpersonal and communication skills to work effectively with cross-functional teams.
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