United Therapeutics Corporation - Durham, NC

posted 18 days ago

Full-time - Mid Level
Durham, NC
Professional, Scientific, and Technical Services

About the position

The Validation Engineer or Specialist II, Equipment at United Therapeutics will support equipment qualification activities, including developing and reviewing protocols and reports, representing Validation on project teams, and assisting with change control requests. This role requires a solid understanding of equipment validation and the ability to resolve moderately complex issues, with opportunities for advancement to a senior level based on experience.

Responsibilities

  • Perform activities in support of equipment qualification including developing and reviewing protocols and final reports.
  • Represent Validation on project teams and assist in preparing Validation change control requests and assessments.
  • Develop and execute protocols and summarize reports supporting validation of equipment, computer systems, and processes.
  • Collect, compile, and analyze validation data and information with minimal supervision.
  • Participate on project teams requiring validation support to represent the function internally.
  • Communicate effectively with colleagues and management to provide the status of validation activities.
  • Contribute to the Validation organization to ensure department goals and objectives are met.
  • Support change control activities from a validation perspective.
  • Revise validation SOPs and lifecycle validation documentation.
  • Perform equipment and other validation-related requalifications and periodic reviews.

Requirements

  • Bachelor's degree in an engineering field and 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 able to prioritize work.
  • Ability to communicate effectively with colleagues and management.
  • Ability to influence and provide guidance to junior team members.
  • Working knowledge of validation datalogger software (Amphenol/Ellab).
  • Working knowledge of TrackWise or comparable quality systems.
  • Working knowledge of regulatory requirements from the US FDA and EU.

Nice-to-haves

  • Ability to qualify analytical equipment such as HPLC, UPLC, Spectrophotometers.
  • Ability to qualify processing equipment including Autoclaves, Isolators, Bioreactors.
  • Ability to qualify utilities such as Purified Water Systems, Compressed Air System.

Benefits

  • Medical, dental, and vision coverage
  • Prescription coverage
  • Employee wellness resources
  • Savings plans (401k and ESPP)
  • Paid time off
  • Paid parental leave benefits
  • Disability benefits
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