Lead Process Engineer/Principal Process Engineer (DPI)

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are 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.

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, and other orphan diseases.

How you’ll contribute

The Lead Process Engineer (DPI) will provide process engineering expertise for new facility projects, with a core focus on Tyvaso DPI related projects. Responsibilities include serving as the project point person from conceptual plan, detailed design, and construction. Additional responsibilities include equipment/process feasibility assessments, throughput analysis, process specification, and constructability assessments.

• Serve as the key project point person from conceptual plan to detailed design and construction for critical success of new DPI facility and future expansions (process & facilities)
• Support overall strategic planning, and achievement of goals for new facility
• Support and drive tech transfer interactions required for starting up new commercial DPI facility
• Participate in and present process and project plans to A&E firms to evolve concepts and construction documents
• Participate and lead process interactions with CM firms for pricing and approval
• Develop expertise with bulk powder formulation and fill/pack facility
• Review construction submittals and RFIs
• Routinely interact with vendors/partners, Manufacturing, QA, QC, Facilities, Validation, and EHS personnel to achieve project and production goals
• Write new equipment URS’s
• Recommend and implement performance and reliability improvements for facilities and process equipment
• Initiate and own change controls for equipment purchases and modifications
• Provide facility engineering support for the technology transfer of product(s) from existing manufacturing to new facility
• Assist in process development
• Perform other duties as assigned

The Principal Process Engineer (DPI) will:.

• Serve as the key project point person from conceptual plan to detailed design and construction for critical success of new DPI facility and future expansions (process & facilities)
• Drive and support overall strategic planning, and achievement of goals for new facility
• Lead tech transfer interactions required for starting up new commercial DPI facility
• Participate in and present process and project plans to A&E firms to evolve concepts and construction documents
• Serve as Subject Matter Expert (SME) for bulk powder formulation and fill/pack facility
• Responsible for review and approval of construction submittals and RFIs
• Perform other duties as assigned

For this role you will need

Minimum Requirements

• Lead Process Engineer:
• Bachelor’s Degree in Arts/Sciences (BA/BS) in chemical, mechanical, or electrical engineering or equivalent scientific discipline with 8+ years of related industry experience
• 5+ years of experience in pharmaceutical fill finish operations working in process and facility design related to bulk powder formulation (ex. spray drying) and/or fill/pack
• Direct experience with regulated environments (i.e., cGMP, OSHA, EPA)
• Design experience or project ownership experience in pharmaceutical manufacturing, specifically fill finish and/or biologics
• Experience in problem solving, negotiations, presentation and collaborative team-building across multiple geographies and cultures, as well as external parties
• Proficient in Microsoft Office suite

• Principal Process Engineer:
• Bachelor’s Degree in Arts/Sciences (BA/BS) in chemical, mechanical, or electrical engineering or equivalent scientific discipline with 10+ years of related industry experience
• 5+ years of experience in pharmaceutical fill finish operations working in process and facility design (ex. spray drying) and fill/pack
• Direct experience with regulated environments (i.e., cGMP, OSHA, EPA)
• Design experience or project ownership experience in pharmaceutical manufacturing, specifically fill finish and/or biologics
• Experience in problem solving, negotiations, presentation and collaborative team-building across multiple geographies and cultures, as well as external parties
• Proficient in BlueBeam
• Proficient in Microsoft Office suite

Preferred Qualifications

• Lead Process Engineer: Master’s degree (MA/MS/MBA) in chemical, mechanical, or electrical engineering or equivalent scientific discipline with 6+ years of related industry experience
• Principal Process Engineer: Master’s degree (MA/MS/MBA) in chemical, mechanical, or electrical engineering or equivalent scientific discipline with 8+ years of related industry experience
• Experience with designing and qualifying GMP production facilities
• Knowledge of spray drying process control
• Knowledge of disposable single-use systems
• Proficient in AutoCAD or equivalent

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

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