Computer System Validation Specialist
12 hours ago
The role of a Computer System Validation Specialist is to ensure that all computerized equipment and control systems in the manufacturing environment are validated according to regulatory requirements.
This involves generating validation documentation, executing protocols, participating in change control processes, and ensuring compliance with regulatory requirements.
- Develop and execute validation plans for new computerized equipment and control systems.
- Generate comprehensive validation documentation, including protocols and reports.
- Collaborate with cross-functional teams to identify and implement changes to relevant systems.
- Review and approve site change controls to ensure compliance with cGMP.
For this position, we require a degree in Science or Engineering and 3-5 years of experience working in a Healthcare manufacturing environment, preferably in the pharmaceutical sector.
Key Responsibilities:- Design and execute validation studies for manufacturing and control equipment, ensuring accurate and efficient results.
- Provide technical expertise on current US FDA and EU validation requirements, supporting the development of compliant systems.
- Maintain up-to-date validation documentation, ensuring seamless compliance with regulatory standards at all times.
- Approve and implement changes to relevant systems, ensuring minimal disruption to operations.
- Review and approve site change controls, verifying their alignment with company policies and regulatory requirements.
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