Computer Systems Validation

7 days ago


Melbourne, Victoria, Australia PSC Biotech® Corporation Full time $90,000 - $120,000 per year

The Computer Systems Validation Engineer (CSV) 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

  • 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.


  • Melbourne, Victoria, Australia SYPAQ Systems Full time $90,000 - $120,000 per year

    SYPAQis an industry leader in C4ISREW and autonomous systems integration, product development, and consulting services, with established engineering and IT teams across projects in Canberra, Melbourne, Adelaide, Sydney, and Brisbane. Our rich history of partnering with the Australian Defence, National Security community as well as major Federal Government...

  • Systems Tester

    7 days ago


    Melbourne, Victoria, Australia ARRB Systems Full time $60,000 - $100,000 per year

    At ARRB Systems, we believe together we can change the face of pavement management and help our customers make better, more well-informed decisions about their road network. With experience that's been hard-earned over decades, we seek to combine machine intelligence with human intelligence, to deliver incredible value and ultimately make roads safer.We do...


  • Melbourne, Victoria, Australia Mescada Full time $90,000 - $120,000 per year

    CompanyAn opportunity has arisen for a control system validation engineer within an exciting organisation. Our technical competency has led us to be a premier automation and control company. As partners with key system suppliers and a substantial customer base we have new requirements to fill roles in pharmaceuticals, water, manufacturing, oil, gas and...

  • PLM System Analyst

    1 week ago


    Melbourne, Victoria, Australia BAE Systems Full time

    At BAE Systems AustraliaDo interesting work that MATTERSENJOY what you doGROW your careerBe YOUWe work in a thriving sector - one that puts us at the forefront of exciting and meaningful work. Every day we push boundaries to produce some of the world's most innovative and ground breaking technology. Individually we all contribute to our success. Collectively...


  • Melbourne, Victoria, Australia Nerdcore Computers Service Centre Full time $40,000 - $80,000 per year

    If you are going to apply for this role and then waste our time its better you waste another companies valuable time.Company DescriptionNerdcore Computers Service Centre is a leading provider of professional onsite computer repairs and remote IT support services in Australia. With a focus on same-day service and customer satisfaction, we offer repairs and...


  • Melbourne, Victoria, Australia Peoplebank Australia VIC Full time $90,000 - $120,000 per year

    Join a leading Australian financial services provider as a Systems Engineer – End User Computing. Based in Melbourne,  you will be responsible for identifying and fixing security vulnerabilities on end-user devices and applications. Key responsibilities: Identify vulnerabilities on Windows 11, MacOS, and related platformsPerform regular vulnerability...

  • QA Validation

    1 week ago


    Melbourne, Victoria, Australia Evolve Scientific Full time $80,000 - $120,000 per year

    About the role:Global pharmaceutical organisationBased in the Southeast suburbs of Melbourne6-months casual contractMonday to Friday, full time hoursAbout your duties:Ensure manufacturing processes are meeting specificationsDevelop and review validation protocols and reports for equipment, utilities and processesProviding oversight of the sites quality...


  • Melbourne, Victoria, Australia Thales Full time $80,000 - $120,000 per year

    At Thales, we know technology has the ability to make our world more secure, sustainable, and inclusive – and that it's all driven by human intelligence.Because it takes human intelligence to build and power the systems and solutions that people depend on every day. So we stay curious and make space for diverse points of view. We share what we know and we...


  • Melbourne, Victoria, Australia Thales Full time $80,000 - $120,000 per year

    At Thales, we know technology has the ability to make our world more secure, sustainable, and inclusive – and that it's all driven by human intelligence.Because it takes human intelligence to build and power the systems and solutions that people depend on every day. So we stay curious and make space for diverse points of view. We share what we know and we...


  • Melbourne, Victoria, Australia Zoetis Australia Research & Manufacturing Pty Ltd Full time $120,000 - $180,000 per year

    About ZoetisAs the world's leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide – from livestock farmers to...