Field Validation Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure compliance with current Good Manufacturing Practices (cGMP) and the FDA/Grifols Quality Systems throughout the execution, documentation, and review of validation protocols.

• Conduct on-site freezer installation, operational, and performance qualifications at donor centers and associated locations.

• Collaborate with Donor Center and Field Quality/Operations staff to ensure timely and documented validation approvals.

• Analyze validation data to confirm that acceptance criteria are satisfied.

• Contribute to the writing of validation summaries.

• Communicate with Field Quality/Operations and Operational and Quality Assurance teams about compliance and cGMP matters.

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

• Execute test cases as required.

• Prepare validation reports for distribution.

• Ensure that milestones and timelines are adhered to for assigned projects.

• Get validation equipment ready for Donor Center utilization and assessment upon return.

• Assist in determining actions for adding, removing, and/or revalidating processes, systems, and equipment.

• Evaluate new or updated methodologies, applications, and equipment, assisting in resolving performance, transfer, or service challenges.

• Monitor and track process/system failures and incidents.

• Provide feedback to Donor Center management on requirements, collected data, and validation processes.

• Track and monitor due dates for equipment calibration as well as calibration failures/incidents.

• Prepare donor center personnel for validation activities and conduct training when necessary.

• Travel on-site up to 75% to ensure timely completion of validation tasks.

⛳️ Requirements

• Bachelor's degree.

• Generally, 2 years of experience in quality and validation within a cGMP and/or IT setting.

• Strong understanding of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.

• Exceptional quantitative and analytical abilities.

• Outstanding oral and written communication skills.

• Strong critical thinking and problem-solving capabilities.

• Ability to detect errors and recommend corrective actions.

• Capacity to collaborate effectively in a team environment.

• Proficient in Microsoft Office applications and computer software used in Donor Centers.

• Willingness to travel on-site up to 75% as required.

• Ability to work in both office and laboratory/manufacturing settings.

• Capability to work around biological fluids, potential infectious agents, extreme cold, and high noise levels.

• Proficiency in using necessary personal protective equipment.

• Ability to lift and carry items weighing up to 50 lbs.

• Correctable near and far vision as specified in the Occupational Demands Form.

• Depending on the assignment area, directly related experience or a combination of relevant education and experience and/or competencies may be accepted in lieu of the stated requirements.

🏝️ Benefits

• Up to 5% of the company bonus pool.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Paid time off (PTO).

• Paid holidays.

• Up to 5% 401(K) match.

• Tuition reimbursement.

• Opportunities for professional growth and career advancement.