United Therapeutics Corporation-posted about 2 months ago
Full-time • Mid Level
Onsite • Silver Spring, MD
1,001-5,000 employees
Chemical Manufacturing

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!

  • 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
  • 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)
  • 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
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