Senior Process Engineer, Regenerative Medicine Operations

United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.

The job details are as follows:

What We Do

United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.

We currently have 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 company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

How you’ll contribute
The Senior Process Engineer will provide process engineering support for new facility projects as assigned with a core focus on biologic and human regenerative medicine projects. Responsibilities will include serving as the project point person from conceptual plan, detailed design, and construction. Additional responsibilities will include equipment/process feasibility assessments, throughput analysis, process specification, and constructability assessments.

• Participate in and present process and project plans to A&E firms to evolve concepts and construction documents
• Routinely interact with internal R&D, Manufacturing, QA, Facilities, Validation, and EHS personnel to achieve project and production goals
• Participate and lead process interactions with CM firms for pricing and approval
• Subject Matter Expert (SME) for biologics and cell expansion based facilities
• Responsible for review and approval of construction submittals and RFIs
• Independently lead small engineering projects
• Assist in process development
• Provide engineering support for the technology transfer of new products into existing manufacturing operations
• Perform other duties as assigned

For this role you will need

Minimum Requirements

• 5+ years of related industry experience
• Bachelor’s Degree in Arts/Sciences (BA/BS) in chemical engineering or equivalent scientific discipline preferred
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA)
• Knowledgeable of process control systems
• Proficient in Microsoft Office suite
• Proficient in BlueBeam

Preferred Qualifications

• Design experience or project ownership experience in biologics manufacturing and/or human cell expansion for cell/gene based therapies
• Experience in problem solving, negotiations, presentation and collaborative team-building across multiple geographies and cultures, as well as external parties
• Experience with designing and qualifying GMP production facilities
• Direct experience with human cell expansion technologies
• Knowledge of disposable single-use systems
• Specific industry knowledge relevant to biologics, cell expansion, purification, and supporting infrastructure associated with building and process design
• Proficient in AutoCAD or equivalent

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities