Senior Validation Engineer, Equipment (Relocation Assistance Available) at United Therapeutics in Jacksonville, FL

Job description

California, US residents click here . The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are The Senior Validation Engineer, Equipment (LBE) performs activities supporting the full equipment lifecycle. This role directly supports Manufacturing, Quality Control, and Quality Assurance functions by developing, reviewing, and executing validation protocols and final reports. This role represents Validation/Quality Engineering on cross-functional project teams and is responsible for preparing and assessing validation-related change control requests. Key responsibilities also include developing, and/or assist in developing, validation plans, requirements specifications, protocols and final reports. Additionally, this role serves as a liaison between Quality and the Operations Asset Management team to support asset lifecycle management requirements and ensure alignment with regulatory and quality standards. Apply extensive knowledge and skills in equipment validation to support validation activities and maintain a full understanding of validation principles and practices Coordinate validation activities and serve as a technical resource within assigned areas of validation Develop, execute, review, and support approval of validation protocols and reports for equipment, systems, and processes, providing technical input during document preparation and review Collect, compile, analyze, and interpret validation data to confirm and maintain the validated state of equipment for GMP use, working independently with review at critical points Develop, execute, and review validation lifecycle documentation, including but not limited to SOPs, Validation Master Plans (VMPs), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, FAT/SAT, and DQ/IQ/OQ/PQ/PV protocols and reports Support contracted resources by providing direction on validation activities and reviewing documentation for compliance with established requirements Troubleshoot and resolve equipment, system, and process issues using established procedures and sound technical judgment, escalating more complex issues as needed Perform root cause analysis and apply appropriate problem-solving methodologies to address issues of varying scope Conduct gap assessments of validation documentation, systems, and practices, communicate findings, and support implementation of corrective actions and process improvements Provide technical guidance and training on validation policies, procedures, and practices to internal and contracted personnel Support departmental operational goals by providin