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California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

Come join a team of quality-driven professionals supporting GMP compliance with a passion for ensuring product integrity from development through commercial manufacturing. You’ll join a collaborative environment, where your role in reviewing and approving critical documents—such as validation protocols, batch records, and SOPs—helps maintain the highest standards of quality and compliance. You’ll be navigating investigations (OOS, deviations, CAPAs), and partnering with cross-functional teams and CMOs to drive continuous improvement. If you're ready to play a key role in shaping robust quality systems and supporting regulatory success, come join us at United Therapeutics!

+ Collaborate and approve GMP related documents (i.e. IOQ and PQ documents, process validation protocols, analytical/microbiological method validations, stability protocols, operational protocols and reports, etc.) pertaining to APIs and drug products for accuracy, completeness, and compliance with UT policies, quality system procedures, cGMPs and standards

+ Provide QA input to process and manufacturing documentation including material specifications, drawings, inspection procedures, manufacturing and packaging procedures, to ensure that the resulting products can be adequately manufactured and tested

+ Serve as contributor in quality assurance methodologies supporting engineering, manufacturing, and regulatory functions

+ Create or assist in the creation of batch records, protocols, summary reports, standard operating procedures, raw material specifications, etc.

+ Participate in quality system project initiatives, project start-up, and continuous process verification

+ Provide support to QA management during regulatory agency inspections (such as FDA) and participate in the closure of internal and regulatory audit observations

+ Support SME in change management activities and intra departmental relationship building

+ Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations

Additional responsibilities of the Quality Engineer II:

+ Present technical information on projects or areas of expertise

+ Provide oversight to CMO related manufacturing processes, change controls, investigations, and new projects. Perform activities as needed to support operational processes critical to product quality

Minimum Requirements of the Quality Engineer I:

+ Bachelor’s Degree in a scientific/engineering related field

+ Ability to define problems, collect data, establish facts, and draw valid conclusions

+ Strong interpersonal skills and ability to work as an effective team member

+ Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheets

+ Able to work independently with occasional need for guidance

Preferred Qualifications for the Quality Engineer I:

+ 1+ years of relevant pharmaceutical industry experience in a cGMP environment

+ Familiarity with QA and cGMP principles, concepts, validation industry practices, and standards for pharmaceutical operations

+ Demonstrated knowledge of FDA Quality System regulations and cGMP, 21 CFR Part 11, 210, 211, and 820

+ A familiarity with EU, and JP GMP regulations

Minimum Requirements for the Quality Engineer II:

+ Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline

+ 3+ years of relevant pharmaceutical industry experience in a cGMP environment

+ 3+ years of experience in quality assurance, quality engineering, or validation role

+ A clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards

+ Strong technical writing skills

+ A working knowledge of US FDA, EU, and JP GMP regulations

+ Must be proficient in Microsoft Excel, Word, PowerPoint and Adobe Acrobat

Preferred Qualifications for the Quality Engineer II:

+ 1+ years of experience with solid dose drug manufacturing

+ Experience with aseptic processing and media fill programs

+ Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise and Empower software systems

+ Previous experience with validation and facility qualification

+ Previous experience in regulatory inspections

+ Process start up and clinical trial material manufacturing experience

+ Experience performing technology and product transfers

+ Continuous process verification

+ Knowledge of software validation practices and data integrity initiatives

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

_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 job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._