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Validation Engineer

PolyNovo Limited - Port Melbourne, VIC

Source: uWorkin


About the Company

PolyNovo is an Australian based medical device company that designs, develops and manufactures dermal regeneration solutions, such as NovoSorb® BTM, using its patented NovoSorb biodegradable polymer technology.

With US FDA, European CE Mark and other registrations, our resorbable polymer implantable devices are saving lives and enhancing clinical outcomes for patients around the world.

About the Role

Reporting to the Quality Assurance Manager, the role's primary function is to validate PolyNovo's new facility and equipment, as well as provide compliance support across QA, Engineering, Manufacturing and R&D departments to ensure ISO13485 & GMP Quality Management System (QMS) and applicable medical device regulatory requirements are implemented and maintained.

Key Responsibilities 

  • Manage all qualification activities, including preparation and/or review of the respective documentation related to the new facilities, to ensure compliance to internal Quality Management System requirements and to applicable regulatory standards such as ISO, CFR and applicable cGMP.
  • Support the line Manager and wider team in drafting and reviewing qualification documentation of equipment for compliance and improvement opportunities, ensuring that equipment are suitably qualified and calibrated.
  • Work closely with internal teams and consultants to ensure compliance of the manufacturing plant.
  • Assist in engineering reviews & documentation of new facility.
  • Assist in qualification problem solving
  • Review detailed process design drawings including functional & equipment specifications, support the preparation of commissioning and SOP documents
  • Assist with commissioning activities, undertake site inspections and prepare reports and support documentation activities to ensure that quality & operational targets are met in a timely manner
  • Conduct qualification and/or validation activities as requested under general supervision

About You

  • Bachelor’s degree in engineering from an accredited university in one of following disciplines: Engineering Degree (Mechanical, Manufacturing or Industrial preferred)
  • Minimum of 3 years’ experience in a validation- related role within a medical device/pharmaceutical manufacturing or engineering organisation regulated environment. Previous experience with cleanroom set-up and validation is highly desirable.
  • Excellent written and verbal communication skills.
  • Ability to work autonomously and maintain high standards in reporting, documentation and organisation and the quality and timeliness of one’s work.
  • Good understanding of risk management principles and their application in a manufacturing environment.
  • Proficiency in the use of Microsoft Excel, PowerPoint and Word.
  • Production and process development/ improvement experience is an advantage.
  • An understanding of GMP, OH&S requirements is highly desirable.
  • Ability to build good working relationship within and between teams

Apply now via Seek link below.