Computer Systems Validation (CSV) Engineer - Melbourne

biotech; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

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.

Skills

Strategic thinking

Implementation skills

Drive results

Attention to detail

Written & verbal communication

Time management

Team or independent work

Education

Bachelor's in Computer Science or Engineering

Tools

MS Office

Operating systems

Job description

We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a 12-month contract. The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

DUTIES AND RESPONSIBILITIES:

• Write, review, and approve validation procedures, documents, test scripts and final reports in compliance with company policies and standards from regulatory agencies.
• Assists to maintain accurate validation documentation.
• Keep up to date with advances in the field and the regulatory requirements.
• Support involvement in review and updating of validation documentation.
• Assist in reviewing and analysing validation data – compiling reports when required.
• Recommendation of process upgrades and improvements in efficiency.
• Support the implementation of such improvements with upper management.
• Assist in involvement in both internal audits and external inspections as required.
• Additional duties and responsibilities may be assigned from time to time.

Requirements Requirements

• Bachelor’s Degree in Computer Science or Engineering or equivalent experience.
• 2-5 years of experience in computer systems validation experience.
• Demonstrated strategic thinking, implementation skills, and ability to drive results.
• Strong attention to details.
• Ability to follow protocols and procedures.
• Excellent written and oral presentation and communication skills.
• Highly organized in planning and time management, with the ability to multi-task.
• Ability to work with a team or independently.
• Has experience writing, reviewing, and executing validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports.
• Knowledge of operating systems and MS Office desired.
• Knowledge of regulatory, compliance, and validation desired.