Validation Engineer

Katalyst HealthCares and Life Sciences

$80K — $110K *
US-AnywhereRemote in Salt Lake City, UT
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in mechanical engineering
  • Mandatory prior experience in the Medical Device industry
  • Strong knowledge of ISO 13485 and ISO 14971 standards
  • Experience with IQ, OQ, and PQ validation activities
  • Validation planning, execution, and documentation skills
  • Experience in equipment, process, and product transfer validation
  • Strong capability in cross-functional collaboration and stakeholder management

Responsibilities

  • Plan, lead, and coordinate validation activities across projects
  • Support validation execution for various transfers including equipment and products
  • Author and review essential validation protocols and reports
  • Ensure compliance with all regulatory and quality standards
  • Drive project continuity and ensure timely delivery of validation milestones

Benefits

  • Collaborative work environment within cross-functional teams
  • Exposure to a dynamic Medical Device industry
  • Opportunity to lead critical validation projects
  • Development of skills in regulatory compliance and quality assurance
  • Potential for professional growth and career advancement opportunities
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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