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Über
United Therapeutics 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. As our next Senior Quality Engineer, you'll help shape the future of new APIs, drug products, and combination products—from development through commercialization—while keeping our marketed products performing at their best. You'll lead investigations (OOS, CAPAs, change controls, exceptional conditions), approve critical GMP documentation (IOQ/PQ, process and method validations, stability protocols), and serve as a trusted on-site partner to CMC and our CMOs. You'll be a steady, strategic presence during FDA, MHRA, and partner inspections, and a go-to SME when complex quality challenges land on the table. If you're a sharp problem-solver who thrives on ownership, collaboration, and continuous improvement—this is where your work makes a real difference. Minimum Requirements: Bachelor's Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline 5+ years of relevant pharmaceutical industry experience in a cGMP environment with a Bachelor's Degree or 3+ years of relevant pharmaceutical industry experience in a cGMP environment with a Master's Degree 4+ years of experience in Quality Assurance, Quality Engineering, Validation or a Technical Operations role Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards Ability to define problems, collect data, establish facts, and draw valid conclusions Strong organizational skills and strong attention to detail Strong verbal and written communication skills Strong interpersonal skills and ability to work as an effective team member Ability to actively participate in process improvement Strong technical writing skills Working knowledge of US FDA, EU, and JP GMP regulations Proficient in Microsoft Excel, Word, PowerPoint and Adobe Acrobat Ability to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines Job Location: United Therapeutics requires this candidate to be on-site at our Silver Spring, Maryland location 100% of the time.
Sprachkenntnisse
- English
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