Senior Validation Specialist

4 days ago

San Francisco, California, United States SciPro Full time

Job Title: Senior Validation Engineer

Job Summary:

SciPro is seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our validation team, you will be responsible for conducting critical validation activities, including commissioning and qualification, performance qualification, cleaning validation, process validation, and revalidation.

Key Responsibilities:

  • Develop and oversee detailed project plans and timelines for validation execution.
  • Prepare validation documentation, such as protocols, change controls, and summary reports.
  • Lead validation efforts for CD/PQ/CV/PV/RV activities.
  • Serve as project manager, ensuring timely implementation of new systems according to set timelines and budget forecasts.
  • Monitor progress, identify issues, and provide reports on any impact to timelines or complications encountered.
  • Contribute to investigations that could affect validation outcomes.
  • Coordinate the collection, testing, analysis, and reporting of samples in accordance with validation protocols.
  • Support change management for validated equipment, utilities, and facilities.
  • Assist in the creation and refinement of manufacturing documents as needed.

Requirements:

  • BS/MS in Chemical or Biochemical Engineering, or a related field, with a minimum of 8 years (BS) or 6 years (MS) of experience in drug product process R&D, Engineering, Manufacturing, or Technical Services.
  • Proven experience in the pharmaceutical/biotech industry.
  • Expertise in cleaning and sterilization validation, with a solid understanding of qualification requirements in a cGMP environment.
  • Strong project management capabilities.
  • Experience in authoring, reviewing, and executing validation protocols.
  • In-depth knowledge of cGMP regulations or equivalent standards.
  • Familiarity with equipment qualification related to formulation, filling, and packaging in a regulated setting.
  • Ability to collaborate effectively with internal teams, external partners, suppliers, and clients.
  • Operational excellence and industrial engineering expertise is a plus.

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