Computer System Validation Specialist

1 week ago

Lucas Heights, Australia ANSTO Full time

**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.

**About Us**:
**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

**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._

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