Validation Engineer

Katalyst HealthCares and Life Sciences

$80K — $110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in mechanical engineering
  • Proven experience in the Medical Device sector
  • In-depth knowledge of ISO 13485 and ISO 14971
  • Familiarity with IQ, OQ, and PQ validation processes
  • Expertise in validation planning, execution, and documentation
  • Experience with equipment, process, and product transfer validation
  • Ability to collaborate across functions and manage stakeholders

Responsibilities

  • Plan, lead, and coordinate validation activities
  • Execute validation for equipment, processes, and product transfers
  • Author and review validation protocols and reports
  • Ensure adherence to regulatory and quality standards
  • Drive project continuity and ensure on-time delivery

Benefits

  • Collaborative work environment
  • Opportunities for professional development
  • Cross-functional project involvement
  • Ability to work with diverse teams including offshore partners
  • Gaining expertise in compliance and quality assurance standards
Full Job Description
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities.

Key Requirements:
  • bachelor's degree in mechanical engineering
  • Prior experience in the Medical Device domain (Mandatory)
  • Strong knowledge of ISO 13485 and ISO 14971
  • Experience with IQ, OQ, and PQ validation activities
  • Validation planning, execution, and documentation
  • Equipment, process, and product transfer validation experience
  • Cross-functional collaboration and stakeholder management
  • Experience coordinating with customers, manufacturing plants, and offshore teams
  • Project Management / Project Lead experience is a plus

Responsibilities:
  • Plan, lead, and coordinate validation activities
  • Support validation execution for equipment, process, and product transfers
  • Author and review validation protocols and reports
  • Ensure compliance with regulatory and quality standards
  • Drive project continuity and on-time delivery.

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