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Sr Validation Engineer

Cornelius, OR 97124

Posted: 09/11/2023 Employment Type: Contract Job Category: Engineering Job Number: 584516 Is job remote?: No Country: United States

Job Description


Main Purpose of the Position:

The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).

  • Develop and manage the detailed project plans and timelines for the execution of validation activities.
  • Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
  • Lead the execution of CD/PQ/CV/PV/RV activities.
  • Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
  • Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
  • Provide input into investigations with potential validation impact.
  • Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
  • Support the change management system for validated equipment, utilities and facilities.
  • Support the development of manufacturing documents as appropriate.

Qualifications / Requirements:
  • BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8 years with a BS (6 years with MS) experience in drug product
  • Process Research & Development, Engineering, Manufacturing, or Technical Services is required
  • Experience in the pharma/biotech industry is required.
  • Experience with cleaning and sterilization validation is required. Candidate must demonstrate understanding of cleaning and sterilization qualification requirements in cGMP environment.
  • Demonstrated project management skills.
  • Experience authoring, reviewing, and executing validation protocols.
  • Knowledge of cGMPs or equivalent regulations.
  • Working knowledge of formulation, filling, and, packaging, equipment qualification in a regulated environment is required.
  • Ability to work with internal teams, partners, suppliers and customers.
  • Operational excellence and industrial engineering skills are a plus.
  • Professional level written and oral communication skills.

Pay Rate Range: $85-105/hr. Salary will be commensurate with experience. 
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