Computer Systems Validation Engineer

PolyNovo Limited; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Salary packaging

Parental leave

Nurture Days

Online learning access

Diversity & inclusion

Job summary

PolyNovo Limited in Melbourne is seeking a Computer Systems Validation Engineer to join the Manufacturing team. You will assist in implementing and validating computer systems such as MES, eQMS and EMS in line with medical device regulatory standards.

Reporting to the Validation Engineering Manager, you will draft validation plans and protocols, perform IQ/OQ/PQ activities, maintain change control, and ensure documentation meets ISO 13485 and FDA requirements.

Qualifications

• Engineering degree in Computer, Electrical or Software Engineering.
• 2–3 years of computer system validation experience.
• Knowledge of 21 CFR Part 11 (electronic records/electronic signatures).
• Proficient with MS Office tools.
• Excellent written and verbal communication; able to influence across departments.

Responsibilities

• Understand CSV development and equipment specs; execute validation (IQ/OQ/PQ) per SDLC and GAMP guidelines.
• Author validation plans, validation protocols, risk assessments, traceability matrices, and validation reports.
• Assist in SOPs and training materials.
• Provide peer reviews on specifications, protocols and reports.
• Ensure validation activities meet ISO 13485 and FDA requirements.
• Define specifications for equipment/software (PLCs, VB apps, databases, SCADA).
• Draft Change Control and Document Control forms.
• Assist with process improvements and periodic revalidations.
• Maintain validations in accordance with approved schedules.

Skills

CSV experience

Regulatory awareness

MS Office proficiency

Cross‑functional collaboration

Education

Engineering degree (Computer/Electrical/Software)

Validation engineering training

Tools

MS Office

Job description

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 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 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 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 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. We like AI for lots of things… just not résumé review. Your application is read by actual human beings. 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: https://au.polynovo.com/company/