Field Validation Specialist - West BU (Home Office, US)

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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 on the West 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, transfer, or service.

- Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.

- Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes.

- Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable.

- Travels on-site up to 75% as needed to ensure timely validation completion within the Geo.

Knowledge, Skills, and Abilities:

- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.

- Excellent quantitative and analytical skills.

- Excellent oral and written communication skills.

- Strong critical thinking and problem solving skills.

- Ability to identify errors and provide corrective action.

- Ability to work with others in a team environment.

- Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.

Education and Experience:

- Bachelor's degree.

- Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.

- Depending on the area of assignment, directly related experience or a combination of directly related education an