Computer Systems Validation (CSV) Engineer - Melbourne

• 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

• 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.