Computer Systems Validation Engineer

PolyNovo Limited; Melbourne; Sur place; AUD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Career development opportunities

Online learning

Discounts at retailers

Paid parental leave

Novated car leasing

Résumé du poste

PolyNovo Limited in Melbourne is seeking a Computer Systems Validation Engineer to join the Manufacturing team. Reporting to the Validation Engineering Manager, you will assist in implementing and validating computer systems (MES, eQMS, EMS) in accordance with medical device manufacturing standards.

You will draft validation plans and reports, contribute to SOPs, and ensure documentation meets ISO 13485 and FDA requirements, while coordinating with cross-functional teams and maintaining quality

Qualifications

• Engineering degree in a relevant discipline (Computer, Electrical or Software Engineering).
• 2–3 years working in computer system validation or related validation engineering roles.
• Knowledge of 21 CFR Part 11 (electronic records/electronic signature).
• Proficient with MS Office tools and strong documentation ability.
• Excellent written and verbal communication, with cross-functional collaboration skills.

Responsabilités

• Understand CSV development, IQ/OQ/PQ, SDLC, and validation protocols for manufacturing equipment and processes.
• Author validation plans, protocols, risk assessments, traceability matrices, and reports.
• Assist in creating SOPs and training materials; provide peer reviews.
• Ensure quality of software and equipment per ISO 13485 and FDA regulations with proper documentation.
• Develop hardware/software specifications for equipment and systems (PLC, databases, SCADA, etc.).
• Draft Change Controls and document controls; support process improvements.
• Maintain validations and update as needed per schedule.

Connaissances

Written communications

Verbal communication

Teamwork

Problem solving

Data analysis

Documentation

Accountability

Multi-tasking

Formation

Engineering degree in Computer, Electrical or Software Engineering

Outils

MS Office

Description du poste

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.

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.

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

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