Validation Specialist

Katalyst HealthCares and Life Sciences

$95K — $115K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 10+ years of validation experience in Pharma, Biotech, or Life Sciences
  • Hands-on expertise in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Proficiency in equipment, facility, utility, or process validation
  • Deep understanding of GMP, GxP, and FDA regulations
  • Skilled in developing and executing validation protocols and reports
  • Experience with handling deviations, CAPA, change controls, and risk assessments
  • Ability to collaborate effectively with Engineering, Quality, Manufacturing, and Validation teams

Responsibilities

  • Support validation activities in a GMP-regulated environment
  • Develop and execute validation protocols and reports
  • Conduct IQ, OQ, and PQ for various systems and processes
  • Oversee equipment, facility, utility, and process validations
  • Manage deviations, CAPA, change controls, and risk assessments
  • Assist in FAT/SAT, commissioning, and qualification activities
  • Ensure compliance with GMP, GxP, and FDA regulatory requirements

Benefits

  • Flexible work hours
  • Health and wellness programs
  • Professional development opportunities
  • Collaborative team environment
  • Access to the latest industry tools and technologies
Full Job Description
Job summary:
We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment.
Roles and Responsibilities:
  • 10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
  • Hands-on experience with IQ, OQ, and PQ.
  • Experience with equipment, facility, utility, or process validation.
  • Strong knowledge of GMP, GxP, and FDA regulations.
  • Experience developing and executing validation protocols and reports.
  • Experience with deviations, CAPA, change controls, and risk assessments.
  • Experience supporting FAT/SAT, commissioning, and qualification activities.
  • Strong technical writing and documentation skills.
  • bility to work with Engineering, Quality, Manufacturing, and Validation teams.

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