Computer System Validation Specialist

Position Overview

  • 3 Year - Fixed Term | Full Time | $111k - $125k +15.4% super
  • Sutherland Shire location I Flexible Work practices I Health & Wellbeing Programs
  • Great opportunity for an experienced audit professional to join the team

About the Opportunity

The Computer System Validation Specialist is responsible for the upgrading of industrial computer systems used within a pharmaceutical manufacturing environment.  You will ensuring upgrades comply with GAMP and PIC/s regulatory requirements.

Your Duties and Responsibilities

 

  • Undertake Computer Systems Validation audits and upgrade work on various industrial computer or specialised systems such as SCADA, robotics, HMI/PLC based machines, or Data Acquisition Systems (DAS), for the organisation.
  • Prepare and execute Good Engineering Practice (GEP) requirements such as design specifications, procurement specifications, Factory Acceptance Test (FAT) documents, Site Acceptance Test documents, Commissioning Report, Disaster Recovery Procedures, Operation and Maintenance manuals.
  • Provide validation advice and input into new engineering projects for industrial computer, OT or other specialised system related projects at ANSTO and Good Manufacturing Practice (GMP) manufacturing areas such as ANSTO Health and ANSTO Nuclear Medicine (ANM). The extent of this advice and input may extend also to any proposed new manufacturing systems, equipment, computer systems, specialised system, new products and facilities against GMP practice;
  • Facilitate Computer Systems Validation training activities, where required for validation familiarisation and the risk-based approach concept to other project engineers within CAVC as required;
  • Undertake additional duties as required and during period of leave of other staff.

 

Please click here to view the Position Description.

About Us

ANSTO leverages great science to deliver big outcomes.  We partner with scientists and engineers and apply new technologies to provide real-world benefits.  Our work improves human health, saves lives, builds our industries and protects the environment.  ANSTO is the home of Australia's most significant landmark and national infrastructure for research.  Thousands of scientists from industry and academia benefit from gaining access to state-of-the-art instruments every year.
 

Benefits of Working with Us

ANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians. 


We support and reward our employees through eligibility for:

  • Training, development and mentoring opportunities 
  • Performance based salary increases 
  • Work-life balance with generous leave entitlements and flexible conditions

 

If you want to join a world class organisation that's making a difference in the lives of Australians, apply now!

How to Apply

For further technical information relating to this position please refer to the Position Description or contact Kevin Sherlock on (02) 9717 9617.  For all other queries please contact Talent Acquisition on +61 (02) 9717 3740.

 

 

To be eligible for appointment, applicants will require a security and pre-employment medical assessment.

 

 

 

Application closing date:  24 October 2024 at 11:59pm.

 

 

All applicants must be Australian citizens.

 

 

In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.