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Senior Validation Engineer

1 month ago

Hillsboro, United States Tailored Management Full time

Sr Validation Engineer

Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124

Main Purpose of the Position:

The Senior Validation Engineer will be responsible for performing various validation activities, including Commissioning and Qualification, Performance Qualification (PQ), Cleaning Validation (CV), Process Validation (PV), and Revalidation (RV). This role requires managing detailed project plans, preparing validation documentation, leading execution activities, and ensuring systems are implemented within predetermined timelines and financial forecasts.

Responsibilities:

  • Develop and manage detailed project plans and timelines for validation activities.
  • Prepare validation and change control documentation, including protocols and summary reports.
  • Lead the execution of CD/PQ/CV/PV/RV activities.
  • Act as project manager for validation deliverables, ensuring adherence to timelines and budget.
  • Track and report issues impacting predetermined timelines.
  • Provide input into investigations with potential validation impact.
  • Coordinate sample collection, testing, analysis, and reporting per validation protocol.
  • Support the change management system for validated equipment, utilities, and facilities.
  • Assist in the development of manufacturing documents as appropriate.

Qualifications / Requirements:

  • BS/MS in Chemical, Biochemical Engineering, or related field/experience.
  • Minimum of 8 years (BS) or 6 years (MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services.
  • Experience in the pharma/biotech industry, specifically with cleaning and sterilization validation.
  • Demonstrated understanding of cleaning and sterilization qualification requirements in a cGMP environment.
  • Proven project management skills.
  • Experience in authoring, reviewing, and executing validation protocols.
  • Knowledge of cGMPs or equivalent regulations.
  • Familiarity with formulation, filling, packaging, and equipment qualification in a regulated environment.
  • Ability to collaborate with internal teams, partners, suppliers, and customers.
  • Operational excellence and industrial engineering skills are a plus.
  • Professional level written and oral communication skills.