Validation Analyst II

Job Summary Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you're someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Validation Analyst II This is What You'll Do 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. Ensure 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 collection volumes Changes in plasma bottle size Changes in plasma collection process Analyzes and interprets validation and study data to determine if requirements are met. 12. Reviews and approves executed equipment validation testing protocols. 13. 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. This is What it Takes Bachelor's degree in IT, life science or related field required. Three years' experience 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 Physical Requirements Do Satisfying Work. Earn Real Rewards and Benefits We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. 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