Innovative Biotechnology / Medical Device company
State of the art plant, high end products
Expanding company offering excellent career prospects
Fantastic opportunity for an Engineer with strong experience in Process Development or Validation to join the market leader in Medical Devices
Award winning and privately owned, this South Auckland Medical Device manufacturing company is undergoing further expansion.
They have developed cutting edge tissue regeneration technology, with the main emphasis of the company being improvement of patient welfare, simplifying operating procedures and reducing healthcare costs.
They currently seek a Process Validation Engineer with sound experience in medical device / pharmaceutical process development or process validation, to perform and document validations of medical device manufacturing processes
Responsibilities include :
Validation and implementation of medical device manufacturing processes
Preparation of statistically valid sampling plans
Characterization of processes and their outputs / acceptance criteria
Written preparation of applicable validation reports that meet regulatory / company standards.
Prepare and maintain accurate documentation consistent with the requirements of applicable regulations and the clients Quality Management System (where applicable).
The ideal candidate will bring :
Bachelor’s Degree in Mechanical Engineering, Polymer Engineering or Biomedical Engineering, or related field
Minimum 3 years’ experience in medical device / pharmaceutical process development or process validation.
Strong grounding in statistics, especially as related to process validation.
Proficient in MS Office applications, especially Excel and Word.
Fluent written and spoken English
Excellent analytical and problem-solving skills
Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
Experience in one or more of the following advantageous : packaging design / validation; resorbable polymers; sterilization validation.
A highly motivated, results driven attitude
This role can either be structured as a 12 month fixed term contract, or a permanent position.
To learn more about this exciting opportunity, apply online today with a CV and Cover letter in WORD format only to gareth str.
co.nz quoting reference number 02 / 1909 / GR