Grifols · 11 hours ago
Validation Specialist
North Carolina, United States
Full-time
Hybrid
Entry, Mid Level
2+ years expGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. The Validation Specialist role involves ensuring compliance with Good Manufacturing Practices and FDA regulations, developing operating procedures, and facilitating validation testing to ensure quality assurance in the production process.
BiotechnologyHealth CareManufacturing
Responsibilities
Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation
Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation
Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required
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:
Write test cases to validate critical control points, user requirements, and functional designs
Execute test cases as needed
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
Assists in writing validation summaries
Ensure milestones and timelines are met on assigned projects
Prepares validation reports for distribution
Evaluates adequacy of corrective actions
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
Monitors and trends customer complaints and nonconformance related to equipment failures
Qualification
Required
Bachelor's degree
Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment
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
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase