Validation Technician

Want to Expandyour 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 TechnicianThis is What You'll DoDevelops 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 and execution of equipment validation protocols.Develops, executes, and maintains validation protocols for donor center, laboratory, and plasma storage warehouse equipment - including freezers, refrigerators, Anti-D refrigerators, and supply room temperature mapping - ensuring alignment with cGMP, GAMP, and good engineering practices.Develop protocols for temperature studies (e.g., plasma thawing, volume changes, collection process modifications)Analyzes resulting data to ensure product quality and compliance with regulatory standards.Reviews, approves, and summarizes executed validation protocols, investigates deviations, and ensures timely resolution of nonconformities.Maintains strict adherence to the organization's SOPs, FDA and EU regulations, and state/local laws governing equipment validation and plasma storage quality.Performs other duties as assigned.This is What it TakesThree (3) years' experience biologics, drug manufacturing, or medical device industry or FDA regulated laboratory.One (1) year of validation or relatable experience in regulated industry.Prior use of use of equipment: calibrated, temperature monitoring, data loggers, etc. preferredAbility to travel up to 40%.Physical RequirementsPosition works at donation centers fleetwideAbility to view video display terminal images 18" away from face for extended periods of timeAbility to sit for extended periods of timeAbility to use a computer and other office equipmentAbility to occasionally lift and carry up to 20 poundsAbility to reach, bend, and stoop as necessaryAbility to communicate effectively, both verbally and in writingAbility to focus and concentrate on tasks for extended periodsAbility to navigate the office environment safely, including stairs and elevators (if applicable)Ability to travel up to via airplane or vehicleAbility to use assistive devices if needed for mobility or communicationAbility to work in temperature-controlled environments, including temperatures as low as -40CDo Satisfying Work. Earn Real Rewards and BenefitsWe'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 trainingOutstanding plans for medical, dental, and vision insuranceHealth savings account (HSA)Flexible spending account (FSA)Tuition ReimbursementEmployee assistance program (EAP)Wellness program401k retirement planPaid time offCompany paid holidaysPersonal timeWith donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.Interested? Learn more online and apply now at:octapharmaplasma.comAnd if you know someone else who'd be a great fit at Octapharma Plasma, Inc. please forward this post