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Sr. Validation Engineer

Sr. Validation Engineer

6 month contract to hire

South Suburbs of Chicago

Hourly Rate: Open to negotiation

Biopharmaceutical Industry

Main Responsibilities and Accountabilities:

  • Responsible for testing the systems (equipment, utilities, facilities, and processes) used to develop or manufacture products in a cGMP environment.
  • Plans, communicates and leads scientifically sound validation strategies for small to large scale multi-facetted validation projects including timelines, cost estimates, and assigned resources (validation contractors).
  • Leads assigned resources (validation contractors) to achieve project deliverables, as required.
  • Assists in review of Deviations, Change Controls, Material Change Controls, Document Change Controls as an SME for Validation.
  • Provides technical support/training to Validation department personnel and other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed.

Position Qualifications and Experience Requirements:

  • BS in Engineering, Physical or Biological Science with 5+ years validation experience or Associates Degree with 8+ years related validation experience. Proven demonstration to perform in the role may also be considered.
  • Experience with current US and international regulations, industry guidance and best-practices for the qualification/validation of facilities, utilities, equipment and process support commercial manufacturing

Notes:

  • No per diem, nor relocation expenses.
  • Must be eligible to work in the US without sponsorship
  • C2C not eligible

Sthree US is acting as an Employment Business in relation to this vacancy.