United Therapeutics Corporation · 2 hours ago
Senior Validation Engineer or Specialist, Equipment
Silver Spring, MD
Full-time
Onsite
Senior Level
$100K/yr - $135K/yr
5+ years expUnited Therapeutics Corporation is a pioneering biotech company dedicated to developing novel pharmaceutical therapies and technologies for rare diseases. The Senior Validation Engineer or Specialist will be responsible for ensuring the compliance and performance of critical manufacturing systems, leading validation projects, and collaborating across teams in a highly regulated environment.
BiotechnologyPharmaceuticalTherapeutics
Hiring Manager
William Neutzling
Responsibilities
Ensure the compliance and performance of critical manufacturing systems including QC lab equipment, and upstream, downstream, and aseptic fill/finish manufacturing equipment
Develop sterilization cycles and write validation protocols from scratch
Lead complex validation projects and troubleshoot unique challenges
Collaborate across teams to uphold the highest industry standards
Qualification
Required
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 datalogger 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
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)
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
More
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2025-12-29
NH Business Review
2025-11-11
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