CSV Engineer - MedTech Manufacturing Systems

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

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.