CSV Engineer – Medical Devices, MES/eQMS Specialist

PolyNovo Limited; Melbourne; On-site; AUD 110,000 - 140,000; Full time

Benefits offered by this job

Career development opportunities

Online learning

Discounts at retailers

Paid parental leave

Novated car leasing

Job summary

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.

Responsibilities

• 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.

Skills

Written communications

Verbal communication

Teamwork

Problem solving

Data analysis

Documentation

Accountability

Multi-tasking

Education

Engineering degree in Computer, Electrical or Software Engineering

Tools

MS Office

Job description

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