Job Overview:
The position of Computer System Validation Engineer is a critical role in ensuring the integrity and compliance of computerised equipment and control systems within a healthcare manufacturing environment.
Main Responsibilities:
* Design, implement, and execute validation studies for manufacturing and control equipment, guaranteeing their seamless integration and functionality.
* Maintain accurate and up-to-date validation documentation through approval and implementation of changes to relevant systems, ensuring transparency and accountability.
* Develop and review validation plans, including execution strategies, to ensure thorough coverage and effective risk management.
* Evaluate and approve site change controls, ensuring they align with established protocols and do not compromise system integrity.
* Ensure unwavering adherence to current Good Manufacturing Practice (cGMP) guidelines at all times, promoting a culture of quality and excellence.
Requirements:
* A degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical) is mandatory, demonstrating a strong foundation in technical principles and scientific inquiry.
* Minimum 3-5 years of experience working in a healthcare manufacturing setting, preferably within the pharmaceutical sector, showcasing expertise and knowledge in industry-specific regulations and best practices.
* At least 2-3 years of experience in validation environments, having honed skills in protocol development, execution, and documentation.