Validation engineer

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Job description

Change Management: Change Control process

  • Management of change requests, approvals, implementation, communication, distribution of information.
  • Manage, coordinate and follow up changes.
  • Perform /initiate change risk analysis.
  • Trigger customer communication work-flows, collect information.
  • Related document management (SOP, forms, checklists).

Risk Management

  • Site risk assessment coordinator.
  • Process FMEA responsible.
  • Leading risk assessments, coordinating teams.
  • Related document management (SOP, forms, risk management tools).

Validation & Qualification

  • Equipment qualification according to “V” model: DQ, IQ and OQ.
  • Equipment validation as per PQ / PV.
  • Participation in projects, being responsible for qualification and validation activities.
  • Create validation / qualification document, assign targets for qualification / validation activities.
  • Maintenance of validation master program.

Required education and experience

  • Engineer, manager or natural science degree (preferred mechanical engineer, technical manager, field of quality engineering)
  • 1-3 years quality / testing experience in manufacturing industry (preferred in GMP environment)
  • fluent English, good coordination skills
  • MS Office, technical writing skill
  • Advantages: knowledge of ISO 15378 / GMP and validation / qualification / change- and risk management experience


  • Vas county

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