Packaging Validation Engineer

Packaging Validation Engineer

Work Type:

Fixed Term Contract

Work Mode:

On-site

Industry:

Engineering

Location:

Chelsea - Victoria 

Salary:

Reference:

BH-29272

As the Packaging Validation Engineer, you will be responsible for planning, executing and documenting packaging validation activities, while ensuring compliance with applicable medical device regulations and industry standards.

Benefits

  • Opportunity to work on an innovative medical device packaging development project
  • Gain experience with complex validation and regulatory projects
  • Excellent culture – Work with a fabulous group of people in a supportive environment
  • State-of-the-art facility | Modern clean-rooms, excellent, comfortable spaces
  • Attractive remuneration package
  • Free on-site parking
 
Skills & experience

To be successful in this role, you will bring:
  • A degree qualification in Engineering, Biomedical Engineering, Mechanical Engineering, Packaging Engineering, Quality Engineering or a related discipline
  • Experience working within a regulated medical device, pharmaceutical, healthcare or life sciences manufacturing environment
  • Demonstrated experience in packaging validation and testing activities
  • Experience developing validation protocols, reports and technical documentation
  • Working knowledge of ISO 13485 and GMP requirements
  • Strong understanding of validation lifecycle principles, risk management, data integrity and document control
  • Excellent analytical, problem-solving and communication skills
  • A proactive, detail-oriented and collaborative approach
Experience with the following will be viewed favourably:
  • ISO 11607-1 and ISO 11607-2 medical device packaging standards
  • ASTM packaging standards including F88/F88M, F1140/F1140M, F1929, F2052 and F1980
  • Packaging and mechanical testing equipment such as seal strength, burst and dye penetration testing systems
  • Statistical analysis using Minitab or similar software
  • Siemens Solid Edge or comparable CAD software
  • ERP systems such as EXACT ERP or similar platforms
 
Key responsibilities include:
  • Developing and executing packaging validation protocols, test plans and reports
  • Supporting packaging performance testing, qualification and validation studies
  • Analysing validation data and providing technical recommendations
  • Ensuring compliance with ISO 13485, GMP and applicable packaging standards
  • Supporting risk assessments, change controls and validation lifecycle activities
  • Creating and maintaining controlled documentation within the Quality Management System (QMS)
  • Participating in internal and external audits
  • Collaborating with cross-functional stakeholders to resolve packaging and validation challenges
  • Supporting continuous improvement initiatives across packaging processes and systems
 
About the company

Our client is a global MedTech company with a global reach. They are a leading provider of innovative medical devices and healthcare solutions and are constantly developing breakthrough technologies that change patient’s lives.
This is an exciting opportunity to play a key role in the validation and compliance of medical device packaging systems, ensuring products meet stringent regulatory, quality, and performance requirements throughout the product lifecycle.
Working within a collaborative and quality-driven environment, you will partner closely with Engineering, Quality, Regulatory Affairs and Manufacturing teams to support critical packaging validation projects and continuous improvement initiatives.

About Veritas Recruitment


Veritas are committed to placing you in the perfect temporary/contract or permanent role, the one thing we do is listen!  We understand the markets in which we work and provide advice on how to leverage yourself for the best opportunities. Our approach is honest, straight forward and responsive. We ensure that you are supported and guided through every step of the process and always treated as an individual.

https://www.veritasrecruitment.com.au/ 

How to apply


If you are a motivated Packaging Validation Engineer looking to further your career within a regulated medical device environment, we would love to hear from you.

Apply now with your resume and cover letter outlining your relevant experience.

Questions can be directed to Leah Creswick at Veritas Recruitment on 0426 842 203.

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