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PSC BiotechPosted 1 month ago

Computer Systems Validation (CSV) Engineer - Melbourne

On-siteMelbourne, Victoria, Australia

ContractBachelors DegreeMedium

Job Summary

Write, review, and approve validation procedures, documents, test scripts, and final reports in compliance with company policies and regulatory agency standards. Maintain accurate validation documentation and assist in analyzing validation data to compile reports as required. Support the implementation of process upgrades and improvements with upper management while assisting in internal audits and external inspections. Keep up to date with advances in the field and regulatory requirements. This 12-month contract role supports the PSC mission to maintain product integrity and enable steady growth, requiring a Bachelor's degree and 2-5 years of experience in computer systems validation.

Required Qualifications

  • Bachelor's Degree in Computer Science or Engineering or equivalent experience
  • 2-5 years of experience in computer systems validation
  • 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

Desired Qualifications

  • Knowledge of operating systems and MS Office
  • Knowledge of regulatory, compliance, and validation

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