Process Engineer
United Therapeutics
Silver Spring, MD

About $71,000 - $97,000 a year

EducationSkills
What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

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.

How you’ll contribute

We are currently looking for a Process Engineer to join our API team. In this role, you will support the process engineering team in the specification, installation, maintenance and operation of small-molecule API production equipment and processes. Additionally, you will partner with members of the API Production and R&D team on activities as required to help internal customers efficiently produce the best medicines possible.

Perform required preventative maintenance operations on existing API equipment stock as described in SOPs, and documents activities via cGMP database (Blue Mountain RAM)
Schedule, manage and communicate PM activities to management and internal stakeholders
Collaborates with stakeholders to help determine the appropriateness of PM operations, and provide documentary support when revising activities in SOPs and forms
Assist with repairing and maintaining the qualified status of common production laboratory equipment within cGMP guidelines.
Direct, manage and collaborate with on-site contractors and suppliers
Document repair activities performed in-house and by contractors according to cGMP requirements
Manage quotes and procure materials as required while observing regulatory and internal purchasing requirements
Assist Calibration team with scheduling, tracking for completing equipment calibrations as required
Prepare monthly spreadsheet of upcoming calibrations and provide Production management with timely information to allow successful calibration activity planning
Initiate Change Control and Document Change Request process flows as required per company and cGMP guidelines, and at Department direction
Accurately describe production concerns, coordinate with management and the Quality team to document changes, and manage task completion
Assist in the specification, purchasing, installation, and qualification testing of equipment in both API Production and R&D departments
Maintain company-specific cGMP training as required, including familiarization with batch processing steps and company-wide procedures
Interface with various internal stakeholder including EHS, Facilities, QC and QA teams
Other Duties and projects as assigned
For this role you will need

Minimum Requirements

Bachelor’s degree in Scientific discipline
1+ year of hands-on mechanical experience in a laboratory
Proficient in Trackwise, Blue Mountain RAM or MasterControl, or similar software package experience used to document activities
Proficient in Microsoft Office
Travel up to 5% or as needed
Preferred Qualifications

Bachelor’s degree in Chemical or Mechanical Engineering
1+ years of experience working a cGMP manufacturing/engineering environment
Prior experience working with laboratory equipment
Familiarity with concepts required to model various mechanical and chemical processes
Familiarity with Blue Mountain Resource Asset Manager, Trackwise, and MasterControl
Experience working with CAD/Visio
Familiarity with risk analysis methods
Familiarity with non-GUI based PLC interfaces
GxP writing experience
Life as a Unitherian

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.

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.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level of job performance and provides state of the art facilities to flourish. This is what makes United Therapeutics a stimulating place to work.

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