Senior QA Engineer

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 bring your quality expertise to therapies that change lives? As our next Senior Quality Engineer, you'll help shape the future of new APIs, drug products, and combination products—from development through commercialization—while keeping our marketed products performing at their best. You'll lead investigations (OOS, CAPAs, change controls, exceptional conditions), approve critical GMP documentation (IOQ/PQ, process and method validations, stability protocols), and serve as a trusted on-site partner to CMC and our CMOs. You'll be a steady, strategic presence during FDA, MHRA, and partner inspections, and a go-to SME when complex quality challenges land on the table. If you're a sharp problem-solver who thrives on ownership, collaboration, and continuous improvement—this is where your work makes a real difference.

The Senor Quality Engineer will support the development of new active ingredients, drug products, and combination products through the design and development, implementation of process verification and validation activities and commercialization, including maintenance and improvement of currently marketed products. Responsible for implementation of standards, methods, and procedures for product development.

• 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
• Lead or collaborate on investigations for quality events, investigations, out of specifications (OOS), change controls, exceptional conditions, 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 Engineering input to process and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
• Participate in project initiatives, project start-up, and continuous process verification
• Serve as an on-site contact for CMC personnel
• Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations
• Support QE management during regulatory agency inspections (FDA, MHRA, etc.) and participate in the closure of internal and regulatory audit observations
• Oversee CMO related manufacturing processes, change controls, investigations, and new projects. Perform “in-plant” activities as needed to support operational processes critical to product quality
• Support SME in change management activities and communicate and resolve quality issues with internal departments. Escalate complex issues to Quality Management
• Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.

Minimum Requirements

• Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
• 5+ years of relevant pharmaceutical industry experience in a cGMP environment with a Bachelor's Degree or
• 3+ years of relevant pharmaceutical industry experience in a cGMP environment with a Master's Degree
• 4+ years of experience in Quality Assurance, Quality Engineering, Validation or a Technical Operations role
• 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
• Ability to actively participate in process improvement
• Strong technical writing skills
• Working knowledge of US FDA, EU, and JP GMP regulations
• Proficient in Microsoft Excel, Word, PowerPoint and Adobe Acrobat
• Ability to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines

Preferred Requirements

• Master’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
• 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
• Familiar 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 on-site at our Silver Spring, Maryland location 100% of the time.

The salary range for this position is $92,500 to $125,000 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.