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 counties, 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 seeking a skilled Computer Systems Validation Engineer to join the manufacturing team. In this role, you will be assisting the Validation Engineering Manager in implementing and validating computer systems applications, with a key emphasis on Manufacturing Execution Systems (MES), Electronic Quality Management Systems (eQMS), and Environmental Management Systems (EMS). Your responsibilities will involve ensuring strict adherence to regulatory standards governing medical device manufacturing.
This is a 12 month fixed term position.
Responsibilities
- Understand the 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 facilities, 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 PolyNovo'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 PLCs, 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.
Other Responsibilities
- Ensure collaborative relationships with PolyNovo team members and external stakeholders.
- Ensure all documentation is reviewed, current and compliant with the quality system and all responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes.
- Ensure behaviour is in line with PolyNovo Values.
- PolyNovo may require you to undertake additional responsibilities or work in other areas than those outlined in this role, subject to business requirements and your skills and competencies.
About You
- Engineering degree in a relevant discipline (Computer, Electrical, Software Engineering), preferably backed by specialist training in validation engineering.
- 2 - 3 years of experience in computer system validation.
- Practical knowledge of 21 CFR Part 11 (electronic records/electronic signatures).
- In-depth knowledge of MS Office tools
- Strong written and verbal communication skills, with the ability to influence others and meet requirements effectively.
- Team-oriented with excellent interpersonal skills and a positive attitude when collaborating with various departments (Engineering, R&D, Manufacturing, Regulatory, etc.).
- Proven track record of accountability for work quality, accuracy, and timeliness.
- Demonstrate high personal and professional standards.
- Ability to handle multiple tasks and prioritize competing responsibilities.
- Strong problem-solving skills with a proactive approach.
- Proficient in data analysis, reporting, documentation, and organizational skills.
- Result-driven and focused on achieving objectives.
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 200 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.
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