Senior Validation Engineer or Specialist, Equipment

California, US residents - .

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.

Are you a validation professional looking to apply your expertise in a dynamic biotech and pharmaceutical environment? As a Senior Validation Engineer or Specialist, Equipment, you’ll be a subject matter expert in equipment validation, playing a key role in ensuring the compliance and performance of critical manufacturing systems—including QC lab equipment, and upstream, downstream, and aseptic fill/finish manufacturing equipment. You’ll leverage your experience in developing sterilization cycles and writing validation protocols from scratch to support a fast-paced, highly regulated environment.

This role offers the opportunity to lead complex validation projects, troubleshoot unique challenges, and collaborate across teams to uphold the highest industry standards. If you’re passionate about driving validation excellence and contributing to life-changing manufacturing for a rare disease population, we want to hear from you!

Minimum Requirements

• Bachelor’s Degree in an engineering field
• 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
• Ability to effectively communicate, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities, to collaborate with peers, senior colleagues, and internal partners, and to present data or information within the broader department or cross-functional areas
• Detail-oriented, self-motivated, and organized with the ability to prioritize work
• Ability to easily adapt to change
• Ability to work with minimal supervision on assigned tasks and projects
• Working knowledge of validation data logger software (Amphenol/Ellab preferred)
• Working knowledge of regulatory requirements from the USFDA and EU related to validation activity
• Working knowledge of word processing, spreadsheets, basic statistical software, and email software
• Ability to perform, review, and oversee equipment process, sterilization, and cleaning qualification for processes that may include Solid Dose, API, Biologics, Fill Finish, and packaging
• Utilize skills as an experienced validation professional with a full understanding of industry practices and company policies and procedures

Preferred Qualifications

• Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems)

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

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…