Senior Quality Engineer

Senior Quality Control Engineer

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. 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.

The Senior Quality Control Engineer 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.

Responsibilities include:

• 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
• Collect, compile, analyze, and interpret validation data to confirm and maintain the validated state of equipment for GMP use
• Develop, execute, and review validation lifecycle documentation
• Support contracted resources by providing direction on validation activities and reviewing documentation for compliance with established requirements
• 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
• Evaluate and support change control activities from a validation perspective
• Participate in internal and regulatory audits by providing validation support and contributing to audit readiness activities
• Serve as an onsite point of contact for contracted validation services for assigned activities
• Maintain equipment and asset data within the Blue Mountain RAM system in alignment with asset lifecycle management requirements
• Perform other duties as assigned

Minimum Requirements:

• Bachelor's Degree in science or engineering field and 5+ years of relevant validation experience in a medical device/cGMP environment
• Solid understanding of validation lifecycle principles, industry best practices, and internal policies and procedures
• Strong written and verbal communication skills, with the ability to effectively collaborate cross-functionally and communicate validation status, technical information, and data to peers, management, and stakeholders
• Highly detail-oriented, self-motivated, and organized, with the ability to prioritize and manage multiple tasks and projects effectively
• Ability to perform, review, and oversee equipment qualification activities
• Working knowledge of validation datalogger systems (Kaye/Ellab preferred). Proficiency preferred
• Working knowledge of applicable regulatory requirements, including FDA and EU guidelines related to validation and GMP activities
• Proficiency in standard business and technical software, including word processing, spreadsheets, email systems, and basic statistical tools

Preferred Qualifications:

• Working knowledge of systems, including computerized information systems, manufacturing control systems (e.g., BMS, DCS, and SCADA systems)

This role is based in our Jacksonville, FL office. Currently this job is a hybrid role requiring at least four days per week in the office. In office requirements could increase to five days per week based on business needs.