CSV Validation Engineer - Regulatory Compliance (12 Mo)

biotech

City of Melbourne

On-site

AUD 90,000 - 130,000

Full time

14 days+

Application generator

Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.

Get past ATS filters

Job summary

biotech is seeking a Computer Systems Validation (CSV) Engineer on a 12-month contract to join our team in Australia. The role covers planning, writing, implementing and reviewing validation protocols for computer-based systems to ensure regulatory compliance.

The successful candidate will have a Bachelor's degree in Computer Science or Engineering, 2–5 years in CSV, and strong documentation, communication, and team-working skills, with the ability to drive results and multi-task in a regulated

Qualifications

Bachelor's degree in Computer Science or Engineering or equivalent experience.
2–5 years of computer systems validation experience.
Ability to follow protocols and procedures.
Excellent written and oral communication skills.
Highly organized with planning and time management, capable of multitasking.
Knowledge of regulatory, compliance, and validation is desirable.

Responsibilities

Write, review, and approve validation procedures, documents, test scripts and final reports.
Maintain accurate validation documentation.
Stay up to date with regulatory requirements.
Review and update validation documentation.
Analyse validation data and compile reports as required.
Recommend process upgrades and drive implementation with management.
Support internal audits and external inspections as required.
Additional duties may be assigned from time to time.