Field Validation Specialist

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

This is a remote position with up to 75% travel for candidates in the Central or East Coast of the United States.
Summary
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.

Primary Responsibilities

• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:

• Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.

• Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
• Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.

• Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.

• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:

• Writes test cases to validate critical control points, user requirements, and functional designs.

• Executes test cases as needed.
• Prepares validation reports for distribution.

• Ensures milestones and timelines are met on assigned projects.

• Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:

• Prepares validation equipment for use at the Donor Center and for evaluation upon return.

• Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance,