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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

You are enthusiastic about GxP quality and looking for your work to make a difference in patients' lives. The Quality Engineer II will provide support to maintain cGMP compliance for UTC commercial products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices. This role will support the implementation of process qualification and validation activities and commercialization including documentation review and process improvement of currently marketed products. Responsibilities for this role also include support of the Change Control, Quality Event, and CAPA programs, Vendor Management, and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits.

+ 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 chemical intermediates APIs and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs

+ Collaborate on investigations for Quality Events, Investigations, Out of Specifications (OOS), Change Controls, and Corrective and Preventive Action (CAPA) processes for cGMP events

+ Create or assist in the creation of Batch Records, Protocols, Summary Reports, Standard Operating Procedures, Raw Material Specifications, etc.

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

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

+ Present technical information on projects or areas of expertise

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

+ Provide support to QA management during regulatory agency and health authorities inspections (FDA, etc.) and participate in the closure of internal and regulatory audit observations

+ 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

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

For this role you will need

Minimum Requirements

+ Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline or 4+ years of relevant pharmaceutical industry experience in a cGMP environment

+ 2+ 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

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

+ Strong organizational skills and strong attention to detail

+ Strong verbal and written communication skills

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

+ Actively participate in process improvement

+ 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

+ Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines

Preferred Qualifications

+ 2+ years of experience with API or drug product 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

+ Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, medical devices, and combination products

+ 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

Job Location

United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location.

The salary for this position ranges from $82,000 to $102,000 per year. In addition, this role is eligible for the Company's short-term and long-term incentive programs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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._