Quality Engineer I

California, US residents click here.

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

Ready to put your quality expertise to work where it truly matters? As our next Quality Engineer I, you'll help safeguard the integrity of life-changing therapies—supporting cGMP compliance across our commercial products, clinical supply, and the next generation of APIs, drug substances, drug products, and combination products. If you're someone who thrives on detail, loves continuous improvement, and wants your work to directly support patients waiting for breakthrough medicines—this is your seat at the table. Come build quality into every step of our mission.

The Quality Engineer I 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 products. This role will support the implementation of qualification and validation activities and commercialization including documentation review and process improvement of currently marketed products. Responsibilities for this role also include support of Change Control, Quality Event, and CAPA programs, 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, 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 the resulting products can be adequately manufactured and tested
• Assist / collaborate on investigations for quality events, deviations, investigations, out of specifications (OOS), change controls, and corrective and preventive action (CAPA) processes for cGMP events
• Provide support to CMO related manufacturing processes, change controls, investigations, and new projects
• Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.
• 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 and project start-up
• 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 communicate and resolve quality issues with internal departments; escalate complex issues to Quality Management, as needed

Minimum Requirements

• Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
• 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
• 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 Requirements

• 1+ years of relevant pharmaceutical industry experience in a cGMP environment
• Familiarity with QA and cGMP principles, concepts, industry practices, and standards
• Demonstrate knowledge of FDA Quality System regulations and cGMP, 21 CFR Part 11, 210, 211, and 820
• A familiarity with EU, and JP GMP regulations
• Familiarity with validation practices
• Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, and combination products

Job Location

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

The salary range for this position is $64,000 to $85,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

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.