Senior Validation Engineer or Specialist, Equipment

Role Summary

Senior Validation Engineer or Specialist, Equipment at United Therapeutics. You will be a subject matter expert in equipment validation, ensuring the compliance and performance of critical manufacturing systems—including QC lab equipment, upstream/downstream, and aseptic fill/finish manufacturing equipment. You will develop sterilization cycles and write validation protocols from scratch, lead complex validation projects, troubleshoot challenges, and collaborate across teams to uphold industry standards. This role is on-site in Silver Spring, Maryland.

Responsibilities

• Lead and execute equipment validation activities across manufacturing systems (QC lab, upstream/downstream, aseptic fill/finish).
• Develop sterilization cycles and write validation protocols from scratch for diverse processes (Solid Dose, API, Biologics, Fill Finish, packaging).
• Collaborate with cross-functional teams to monitor, report, and present validation data and status.
• Provide guidance and oversight on qualification activities, reviews, and approvals.

Qualifications

• Required: Bachelor’s Degree in an engineering field
• Required: 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
• Required: Strong written and oral communication skills; ability to interact with colleagues and management across functions
• Required: Detail-oriented, self-motivated, organized, with the ability to prioritize work and adapt to change
• Required: Ability to work with minimal supervision on assigned tasks and projects
• Required: Working knowledge of validation datalogger software (Amphenol/Ellab preferred)
• Required: Working knowledge of US FDA and EU regulatory requirements related to validation
• Required: Proficiency with word processing, spreadsheets, basic statistical software, and email software
• Required: Ability to perform, review, and oversee equipment process, sterilization, and cleaning qualification for processes across multiple modalities
• Required: Experienced validation professional with understanding of industry practices and company policies
• Preferred: Working knowledge of target systems (CIS, manufacturing control systems, laboratory automation systems, data acquisition)

Education

• Bachelor’s Degree in an engineering field