United Therapeutics Process Development Engineer in Durham, North Carolina

The Job Details are as follows:

Position Overview:

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

Minimum Requirements:

  • 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.