Field Validation Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $69.4k - $104.1k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Grifols

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1909

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. They focus on the development, production, and distribution of innovative plasma-derived medicines and have a strong commitment to research and development in the pharmaceutical sector. Grifols aims to provide solutions for patients with rare diseases and chronic conditions, contributing significantly to the field of biotechnology and healthcare.

📋 Description

• Ensure current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout validation protocol performance, documentation, and review • Execute freezer installation, operational, and performance qualifications on-site at donor centers and affiliated locations • Interact with Donor Center and Field Quality/Operations personnel to facilitate timely, documented validation approval • Analyze validation data to ensure acceptance criteria are met • Participate in writing validation summaries • Communicate with Field Quality/Operations and Operational and Quality Assurance personnel regarding compliance and cGMP issues • Write test cases to validate critical control points, user requirements, and functional designs • Execute test cases as needed • Prepare validation reports for distribution • Ensure milestones and timelines are met on assigned projects • Prepare validation equipment for Donor Center use and evaluation upon return • Assist in identifying actions to add, remove, and/or revalidate processes, systems, and equipment • Evaluate new or updated methodologies, applications, and equipment and help resolve performance, transfer, or service issues • Track and monitor process/system failures and events • Provide Donor Center management with feedback on requirements, collected data, and validation processes • Track and monitor equipment calibration due dates and calibration failures/events • Prepare donor center staff for validation activities and conduct training where applicable • Travel on-site up to 75% to ensure timely validation completion

🎯 Requirements

• Bachelor's degree • Typically 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 • Ability to travel on-site up to 75% as needed • Ability to work in office and laboratory/manufacturing environments • Ability to work around biological fluids, potential infectious organisms, extreme cold, and high noise levels • Ability to use required personal protective equipment • Ability to lift and carry objects up to 50 lbs • Correctable near and far vision as specified in the Occupational Demands Form • 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

🏖️ Benefits

• Up to 5% of the company bonus pool • Medical insurance • Dental insurance • Vision insurance • Life insurance • PTO • Paid holidays • Up to 5% 401(K) match • Tuition reimbursement • Professional growth and career progression opportunities