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Job ID :
56200BR
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; this is a varied role where the projects are data intensive, eye for detail is essential.

Projects can range from gamma irradiation dose mapping through to testing functionality and performance of manufacturing equipment and Involvement with trouble shooting and practical process improvements.


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
  • 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

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 dairy industry
  • Strong production process and/or manufacturing engineering background, with experience in process validations preferred
  • Highly self-directed and results focused
  • Strong data analysis skills and a hands-on technical curiosity
  • Excellent team and interactive skills
  • Excellent written and oral communication
  • High level of internal and external customer focus and responsiveness
  • Project management skills



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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