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Validation Engineer (m/f)

  • Bachelor degree in a scientific / engineering discipline or equivalent
  • Related experience as a validation technician in a rigorous cGMP or similar compliance environment, preferably in the biopharmaceutical, pharmaceutical industry, or dairy industry
  • Strong production process and / or manufacturing engineering background, with experience in process validations preferred
  • Ensuring a high level of conformance to the established quality systems (principles of ISO 9001 and cGMP)
  • Developing, executing, managing and continuously improving the site master validation program, the calibration (metrology) program and engineering quality assurance systems
  • Work closely with QA and senior manufacturing staff
  • Interface with operational teams in resolving quality, procedural and validation variances, as required
  • Present data and project finding to manufacturing leaders
  • Conceive / lead / manage and / or participate in quality improvement initiatives associated with Validations and Engineering
  • Maintaining a high level of cost stewardship
  • Actively participating in customer and regulatory site audits, as required
  • Champion the Engineering Validation function as a team and service based organisation in support of operations at the shop-floor level
  • To carry out any reasonable tasks requested to improve the Company's operations

» Job description

Thermo Fisher Scientific
Auckland [New Zealand]

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