Senior Validation Engineer

Who we are

PolyNovo is a disruptive medical technology company, headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology NovoSorb®. Our lifesaving products have revolutionised the treatment of burns, major trauma as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally.

With a footprint in 46 countries and 300+ staff across a range of locations, PolyNovo continues to grow, and opportunity awaits.

Learn more about PolyNovo by visiting our Website or our LinkedIn page.

About The Role

PolyNovo is currently searching for a Senior Validation Engineer to join the Manufacturing  team. Reporting to the Validation Engineering Manager, the Senior Validation Engineer will be responsible for assisting the Validation Engineering Manager in the development, planning and implementation of process validation in accordance with medical device manufacturing regulatory standards.

Key Responsibilities

Autonomously lead equipment process qualification and process validation projects associated with changes to existing processes/materials, new processes/materials.

Author validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment, and processes.

Assist in the continuous development of risk-based process equipment qualification and validation processes (Protocols, Procedures, Templates etc.).

Work closely with cross-functional teams from the process design stage of new products and take part in the definition of process validation and control strategy.

Provide peer reviews on user specifications requirement, validation protocols, and reports.

Evaluation and review of process validation data, management of change controls and deviations in projects.

Perform process validation periodic review.

Perform equipment qualification and validation activities in accordance with the Quality Management System, Site Validation Master Plan and Validation procedures.

Assist in investigations of qualification and validation deviations (root cause analyses, impact analyses, CAPA definitions).

Participate in change control panels and perform assessment of change controls for impact on facility and equipment cleaning validation status when required.

Qualifications and Experience

Degree qualification in a science, biomedical/biotechnology, engineering, or other relevant discipline.

8-10 years’ experience in a Validation Engineering related role within a medical device/pharmaceutical manufacturing or engineering organization regulated by ISO13485 and/or GMP/FDA 21 CFR820.

Demonstrated knowledge of GMP and Quality Systems such as ISO13485 and/or US FDA 21CFR820 and 21CFR11. Work experience in equipment qualification and process validation.

A growth mindset and a can-do attitude.

Good understanding of design control and risk management processes and their application in a manufacturing environment.

Be an excellent written and verbal communicator, able to influence others in considering one’s viewpoint in meeting requirements.

Capacity to work on many tasks at the same time, sometimes outside of core responsibilities.

Intermediate to advanced proficiency in the use of MS Word, Excel, PowerPoint.

Self-starter, able to work autonomously with the proven ability to take accountability for the quality and timeliness of their work outputs. 

Maintain a high level of reporting, documentation, and organization.

Results focused and demonstrated ability to maintain a high level of data analysis, reporting, documentation, and organization.

Ability to work flexibly at times outside of normal working hours.

Strong attention to detail & a high level of proactive problem-solving skills.

Why PolyNovo?

Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.

Multinational, ASX 300 listed and values-led business dedicated to redefining healing for the benefit of our patients

Unique platform technology, an exciting pipeline of highly innovative products

Diverse, inclusive and flexible workplace culture

Career development opportunities and unlimited access to online learning

Rewards platform with access to discounts at over 450+ Australian retailers

Paid parental leave for primary and secondary carers, Nurture Days, and more

Salary packaging including novated car leasing.

Apply Today

Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted. 

Please note only applicants with full working rights in Australia will be considered.

PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed.

Learn more about PolyNovo at: https://au.polynovo.com/company/