At a Glance
- Tasks: Validate and implement computer systems for innovative medical technology.
- Company: Join PolyNovo, a leading medical tech company based in Melbourne.
- Benefits: Enjoy flexible work culture, career growth, and discounts at 450+ retailers.
- Other info: Be part of a diverse team dedicated to innovation and healing.
- Why this job: Make a real impact on patient lives with cutting-edge technology.
- Qualifications: Engineering degree and 2-3 years experience in computer system validation.
The predicted salary is between 82800 - 101200 $ per year.
Who We Are
Poly Novo is a disruptive medical technology company, headquartered in Melbourne.
We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology Novo Sorb®.
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, Poly Novo continues to grow, and opportunity awaits.
Learn more about Poly Novo by visiting our Website or our Linked In page.
About The Role
Poly Novo 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 - e QMS 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 new 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 Poly Novo's software applications and equipment by validating/qualifying to specifications.
Provide comprehensive documentation (specifications and validation/qualifications) to meet ISO 13485 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 Poly Novo?
Join a team that values innovation, collaboration, and professional growth.
At Poly Novo, 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.
Poly Novo 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.
Please note only applicants with full working rights in Australia will be considered.
- Learn more about Poly Novo at: https://au. polynovo. com/company/
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Computer Systems Validation Engineer in Melbourne employer: PolyNovo Limited
PolyNovo is an exceptional employer located in Melbourne, offering a dynamic and inclusive work culture that prioritises employee growth and development. With a commitment to innovation in medical technology, employees benefit from unique career advancement opportunities, access to extensive online learning resources, and a supportive environment that values diversity and collaboration. The company's focus on quality and patient safety ensures that every team member plays a vital role in making a meaningful impact on lives globally.
