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Intellectt INC
Validation EngineerIntellectt INC • MA, United States
Validation Engineer

Validation Engineer

Intellectt INC • MA, United States
Hace 21 horas
Tipo de contrato
  • A tiempo completo
  • Quick Apply
Descripción del trabajo

Senior / Mid-Level Validation Engineer
Locations: Boston, MA
Duration: 4 6 months, strong possibility of extension
Rate: $41.60 $56.80/hr W2
Work Arrangement: Onsite

Position Overview
Seeking Validation Engineers to support requalification and revalidation activities across manufacturing equipment, facilities, utilities, and processes within a regulated pharmaceutical/biotech environment.

Responsibilities

  • Author and execute validation/revalidation protocols.
  • Support equipment, facility, utility, and process requalification.
  • Perform validation gap assessments and impact assessments.
  • Review test results and investigate discrepancies.
  • Prepare validation reports and inspection-ready documentation.
  • Support change controls, risk assessments, and remediation activities.
  • Collaborate with QA, Engineering, and Manufacturing teams.
  • Ensure compliance with FDA, cGMP, and internal procedures.

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • 5+ years of validation experience; 10+ years preferred for Senior level.
  • Hands-on experience authoring and executing validation protocols.
  • Experience with equipment, facility, utility, and/or process validation.
  • Strong understanding of cGMP and FDA requirements.
  • Strong technical documentation and communication skills.
  • Pharmaceutical, biotech, sterile, or aseptic manufacturing experience preferred.
  • CQV, lifecycle validation, and risk-based validation experience is a plus.
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Validation Engineer • MA, United States

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