Equipment Validation Expert

3 days ago


Hillsboro, United States TalentBurst Full time
Job Title: Equipment Validation Expert

TalentBurst is searching for an exceptional Equipment Validation Expert to contribute to our team in Hillsboro, OR.

Job Summary:

The Equipment Validation Expert will support the development, execution, and management of validation activities and change management systems for validated equipment, utilities, and facilities. This critical role requires a highly skilled professional with a strong background in validation engineering, technical writing, and project management.

Key Responsibilities:
  • Leading the development, execution, and management of CA/SIA/RTM/DIA/URS activity timelines.
  • Tracking and trending activities, reporting on issues impacting predetermined timelines and problems as needed.
  • Ensuring validation activities are executed according to established protocols.
  • Supporting the change management system for validated equipment, utilities, and facilities.
  • Contributing to the development of formulation, filling, and packaging area SOPs and manufacturing documents.
Requirements:

Applicants must meet the following criteria:

  • A BS in chemical, biochemical engineering, or a related field/experience, with a minimum of 2 years experience in process engineering, validation engineering, or Technical Services.
  • Superior technical writing skills.
  • Mandatory cleaning and sterilization qualification experience.
  • Desirable experience in the pharma/biotech industry, with knowledge of cGMPs or equivalent regulations.
  • Familiarity with formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
  • Proven project management skills.
  • Ability to work collaboratively with internal teams, partners, suppliers, and customers.
  • Desirable operational excellence and industrial engineering skills.
  • Exceptional written and verbal communication skills.

The estimated annual salary for this position is approximately $90,000-$120,000, contingent upon experience.



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