Validation Analyst II

Responsibilities

• Develops and maintains equipment validation policy and adheres to regulatory requirements.
• Performs the development and execution of process validation protocols and documents consistent with FDA and EU guidelines.
• Ensures regulatory requirements are met during development of equipment validation protocols.
• Demonstrates an understanding of and the use of all OPI systems.
• Develops equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
• Develops and maintains donor center freezer, refrigerator, and Anti‑D refrigerator validation protocols to be executed fleetwide.
• Develops and maintains donor center supply room temperature mapping protocols to be executed fleetwide.
• Develops and maintains laboratory freezer and refrigerator validation protocols.
• Develops and maintains plasma storage warehouse freezer and processing area validation protocols.
• Develops protocols for temperature studies to include, but not limited to:
• Plasma case and unit thaw
• Changes in plasma bottle size
• Changes in plasma collection process
• Analyzes and interprets validation and study data to determine if requirements are met; reviews and approves executed equipment validation testing protocols; develops equipment validation summaries to support executed protocol and address deviations found during execution.
• Performs deviation investigations identified during the equipment validation process and ensures timely resolution of all nonconformities.
• Supports entire fleet of donor centers through meeting established SLA requirements when responding to requests.
• Supports laboratory and plasma storage warehouse through meeting established SLA requirements when responding to requests.
• Manages support ticket documentation and statuses through to closure.
• Ensures quality of plasma units across donor center fleet prior to shipping through assessment of product exposed to temperatures outside of acceptable range.
• Responsible for ensuring customer is notified when shipped product may have quality impact.
• Ensures equipment performance meets quality and regulatory requirements through assessment of major repairs performed on equipment across donor center fleet, laboratory, and plasma storage freezer.

• Bachelor’s degree in IT, life science or related field required.
• Three years’ experience in biologics, drug manufacturing, or medical device industry or FDA regulated laboratory required.
• Minimum of two (2) years of validation experience in regulated industry required.
• Minimum of two (2) years of software validation experience required.
• Demonstrated knowledge of cGMPs, FDA regulations, SOP implementation, and validation principles and compliance standards.
• Completion of GAMP training.
• Demonstrated excellent interpersonal, written, and verbal communication skills.
• Demonstrated ability to work independently.
• Demonstrated experience working with all levels in an organization.
• Normal amount of travel is expected and may be up to 15%. Requirements may increase depending on business need.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition Reimbursement
• Employee assistance program (EAP)
• Wellness program
• 401k retirement plan
• Paid time off
• Company paid holidays
• Personal time