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Job ID :
42139BR
Location :
New Zealand - Auckland
:
Job Description

We are looking for a permanent Validation Engineer at our Penrose facility in Auckland to support our manufacturing operations. This role performs calibration and validation of equipment and systems; develops procedures, protocols, methods, techniques and evaluation criteria for obtaining results; and is a part of quality improvement teams.


Responsibilities
  • 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
  • Assisting with Engineering and facilities responsibilities
  • Interfacing with operational teams in resolving quality procedural and validation variances, as required
  • Conceiving/leading/managing/participating 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‚Äôs operations

Skills, Experience and Education
  • 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 diary industry
  • Strong production process and/or manufacturing engineering background, with experience in process validations preferred
  • Technical knowledge base in cGMP validation concepts and techniques
  • Highly self-directed and results focused
  • Excellent team and interactive skills
  • Excellent written and oral communication
  • High level of internal and external customer focus and responsiveness
  • Experience in a cGMP environment
  • Project management skills


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