United Therapeutics Process Development Engineer in Durham, North Carolina
The Job Details are as follows:
Responsible for design, set-up, and maintenance of custom equipment for the production of tissue-based regenerative medicine products.
Key Accountabilities / Responsibilities:
Lead design scale-up and improvements of existing R&D systems for commercial robustness
Prepare equipment for translation to GMP manufacturing
Review process and instrument schematics and design drawings
Conduct supplier site visits
Write SOPs, Validation Protocols, Qualifications Protocols, Batch Records, etc., for complex validations, novel equipment and processes
Develop custom single-use assemblies
Implement and test pilot scale systems/batches
8+ years of post-baccalaureate experience in engineering
3+ years of process engineering experience in biotech/pharma
Competency in mechanical CAD, SolidWorks preferred
Intermediate level knowledge of standard office productivity tools (MS Office, Adobe, Project, Visio, etc.)
Preferred Knowledge, Skills, and Abilities:
General knowledge of the regulatory and compliance requirements for design controls and combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, 93/42/EEC)
Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines
Ability to present to senior management, and defend strategy, timing, resource needs and risks
Solid time management and follow-through skills with the ability to work on and manage multiple tasks and projects with tight deadlines
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.