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Senior Validation Engineer

3 months ago

Hillsboro, United States TalentBurst, an Inc 5000 company Full time

Title: Sr Validation Engineer, Req#: ROCGJP00027216

Location: Hillsboro, OR (100% onsite)

Duration: 4+ months Contract (with the possibility of extension based on performance)

Schedule: Monday - Friday and weekend on-call support


Job Description:

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).


Education and Experience:

  • 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.
  • Recent Autoclave validation experience is required.
  • Experience with cleaning and sterilization validation is required.
  • Candidate must demonstrate an understanding of cleaning and sterilization qualification requirements in the 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.


Key Responsibilities:

  • 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.