About the Job
An exciting opportunity has arisen for a Validation Engineer to join our dynamic validation team. This role focuses on managing the validation of computerized systems, specifically in the medical device industry.
Key Responsibilities:
* Validation Lifecycle Management: Provide technical validation support throughout the full validation lifecycle, ensuring alignment with site objectives.
* Develop, review, and approve validation plans, protocols, discrepancy reports, and summary reports.
* Protocol Development and Execution: Utilize engineering, vendor, and customer specifications to create and execute equipment testing protocols while adhering to company and customer procedures and good documentation practices.
* Compliance and Improvement: Maintain detailed knowledge of pharmaceutical and automation processes, ensuring compliance with all applicable regulations and standards.
* Data Analysis and Reporting: Collate, analyze, and report validation data and metrics to stakeholders.
* Support Quality Management Systems: Provide validation expertise for change controls, deviations, and CAPA processes.
* Update and maintain validation Standard Operating Procedures (SOPs) per site and corporate requirements.
* Project Coordination: Manage and prioritize validation-related projects to align with site priorities.
Qualifications:
* Bachelor's degree in Science, Engineering, or a related field.
* Strong understanding of cGMPs and global regulatory requirements.
* Demonstrated problem-solving skills with excellent oral and written communication abilities.
* Minimum of 3 years' experience in a similar role.
Preferred Experience:
* Expertise in equipment qualification and the validation lifecycle.
* Familiarity with Quality and Document Management Systems such as TrackWise (Deviations, CAPA, Change Control), Maximo, CDOCs, and Kneat.
* Ability to work independently, proactively, and in collaboration with cross-functional teams.
* Strong organizational skills and adaptability in managing multiple tasks within project environments.