Field Validation Specialist - West BU

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.

Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Bio Mat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.

• 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.
• 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.

• 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.

• 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 and experience and/or competencies may be considered in place of the stated requirements. Example:
  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands Form # 34:
Work is performed in an office and a…