Quick Info
Experience Level
Entry LevelMinimum Degree
AssociateDepartment
Quality Assurance ControlJob Type
Full TimeSpecialty Skills
cGMPFDA regulatory requirementsCell/Gene/Viral therapy productsAseptic practicesclean room operationsTemperature MappingE-VAL ProEMA regulations
About the Role
The Validation Engineer I is an entry level position and will support the efforts of the Validation department. Responsible for the creation & review of Commissioning, Qualification, Validation protocols and Reports. Responsible for the creation & review of Validation Risk Assessments and System Impact Assessments. Responsible for the execution of Commissioning, Qualification, and Validation protocols. Represent Department in Project Team meetings, as applicable. Serve as liaison with outside vendors as a representative of Matica validation team. Interact with Project Teams and Cross-functional groups. Address and/or escalate site compliance problems and issues to Management. Ensure compliance with appropriate internal and regulatory policies and procedures. Determine and develop Validation approaches and resolve complex Validation issues, working closely with cross functional teams to address deviations as well as recommend and implement corrective and preventative actions. Execute Validation projects and ensure adherence to schedule Communicate Validation requirements, timelines, and resource needs to Validation management Maintain Validation equipment and documentation to ensure organization and audit readiness Promote Quality culture across functions. Must be flexible and able to effectively manage multiple competing priorities. Perform other duties as assigned.
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