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 Computer Systems Validation Engineer to join the Manufacturing team.
Reporting to the Validation Engineering Manager, you will be responsible for assisting in the implementation and validation of computer systems applications (primarily for Computer Systems e.g. Manufacturing Execution Systems – MES, Electronic Quality Management System - eQMS and Environmental Management System - EMS) in accordance with medical device manufacturing regulatory Standards.
Key Responsibilities
Understand development of CSV and equipment specifications and executing Computer System Validation, System Development Life Cycle (SDLC), and other medical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
Author validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for recent and existing manufacturing facility, equipment, and processes.
Assist in the creation of Standard Operating Procedures (SOPs) and training materials.
Provide peer reviews on specifications, protocols and reports.




To ensure the quality of our PolyNovo's software applications and equipment by validating/qualifying to specifications.
Provide comprehensive documentation (specifications and validation/qualifications) to meet ISO ***** and FDA regulations.
Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
Draft Change Control and Document Control forms.
Assist with Process Improvements.
Assist in maintaining all Validations by reviewing periodically according to the approved schedule and updating them, if required.
Qualifications And Experience
Engineering degree in a relevant discipline (Computer, Electrical, Software Engineering) preferably backed by specialist training in validation engineering;
Work experience of 2-3 years in computer system validation
Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature).
In depth knowledge of MS Office tools
Excellent written and verbal communications, able to influence others in considering your viewpoint in meeting requirements.
Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D;, Manufacturing, Regulatory, etc.)
Proven ability to take accountability for the output,



quality, accuracy and timeliness of their work.
Demonstrate high personal and professional standards.
Capacity to multi-task and balance competing priorities, sometimes outside of core responsibilities.
Demonstrated proactive problem-solving skills.
Demonstrated ability to maintain a high level of data analysis, reporting documentation and organization.
Why PolyNovo
Join a team that values innovation, collaboration, and professional growth.
At PolyNovo, we offer a dynamic work environment and the chance 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.
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No automated screening tools are used in our hiring decisions.
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: company/
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📌 Computer Systems Validation Engineer (Melbourne)
🏢 PolyNovo
📍 Melbourne