United Therapeutics Corporation · 7 hours ago
Validation Engineer or Specialist II, Equipment
Triangle Area
Full-time
Onsite
Entry, Mid Level
2+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies for organ transplantation. The Validation Engineer or Specialist II, Equipment will perform activities in support of equipment qualification, including developing protocols, reviewing reports, and providing validation support on project teams.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Work under general supervision to apply broadening and developing validation expertise, skills, experience, and knowledge at the professional level to apply a solid working knowledge of equipment validation to resolve moderately complex issues and consult with higher-level staff for more complex issues
Develop and execute protocols and summarize reports supporting validation of equipment, computer systems and processes
Collect, compile and analyze validation data and information with some or minimal supervision, demonstrating ownership of data to confirm the validated state of the equipment for GMP use
Participate on project teams requiring validation support to represent the function internally on specific projects
Exercise judgment within generally defined procedures and practices to determine appropriate action or to recommend alternative solutions
Communicate effectively, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities. Collaborate with peers and senior colleagues
Contribute to the Validation organization to ensure department goals and objectives are met. Contributions may include leading small initiatives with limited resource requirements, and/or complexity
Support change control activities from a validation perspective in order to meet department goals and objectives
Revise validation SOPs and lifecycle validation documentation
Perform equipment and other validation related requalifications and periodic reviews with general supervision
Qualification
Required
Bachelor's Degree in an engineering field for Validation Engineer II, Equipment
Bachelor's Degree in a Scientific Field for Validation Specialist II, Equipment
2+ years of relevant validation experience in a pharmaceutical/cGMP environment
Working knowledge of Microsoft Office and email software
Detail-oriented, self-motivated, organized, and have the ability to prioritize work
Ability to communicate effectively, both written and orally, with colleagues, management and senior management - cross-functionally
Easily adapts to change
Ability to influence and may provide guidance to junior or support team members
Ability to work with minimal supervision
Working knowledge of validation datalogger software (Amphenol/Ellab) use to perform temperature/humidity mapping
Working knowledge of TrackWise, MasterControl, Blue Mountain RAM or comparable quality systems and/or electronic document management systems
Working knowledge of regulatory requirements from the US FDA and EU
Ability to communicate with regulatory agencies, when applicable
Ability to qualify Solid Dose, Dry Powder, API, Fill Finish, and/or Packaging processing equipment
Preferred
Ability to qualify QC/analytical equipment that may include HPLC, UPLC, Spectrophotometers, LAL Readers, TOC Analyzers
Ability to qualify processing equipment that may include Autoclaves, Isolators, Bioreactors, Tanks, Depyrogenation Tunnel, Blow Fill Seal, Fluid Bed Granulator, Tablet Press, Tablet Coaters, Packaging Lines, Spray Dryers, Vision Inspection Systems
Ability to qualify utilities that may include Purified Water Systems, Compressed Air System, Nitrogen, HVAC, WFI System
Benefits
Medical / dental / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
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 (10)
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
2026-01-15
2026-01-09
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