Validation Specialist

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**The Opportunity**:

- **New Validation Specialist role in CSIRO’s Manufacturing Business Unit.**:

- **Play a critical role in ensuring processes meet quality and regulatory requirements**.
- **Join Australia’s National Science and Innovation Agency**

At CSIRO we accelerate sustainable, globally competitive manufacturing for Australia through leading-edge, commercially viable and scalable solutions. The Manufacturing Business Unit is industry’s innovation partner, working together to transform and build sovereign capability by developing new processes, materials and products.

The Validation Specialist is responsible for the management and execution of validation activities for equipment, processes, and cleaning protocols used in the CSIRO Regulated Biomanufacturing Group. Such validation activities will pertain to both the introduction of new manufacturing processes and modification of existing processes. These functions are a critical aspect to ensure manufacturing processes are measurable, repeatable and compliant in meeting both quality and regulatory requirements.

**Your duties will include**:

- Building and maintaining strong collaborative relationships with key stakeholders to ensure qualification/validation activities are planned and delivered in an efficient timeframe.
- Autonomously leading, planning and executing qualification/validation projects from end-to-end (from procurement to project hand-over) under CSIRO Quality Management System including: Equipment qualification, Process Characterisation / Development Studies, Process Validation (autoclave, Water for Injection, cleaning, environmental monitoring) and Routine revalidation of validated processes.
- Developing and executing validation documents (protocols, reports, risk analyses) that will be integrated into the over-arching Validation Master Plan.
- Investigating and leading through to completion in a corrective action plan any deviations and investigations (impact analyses, root cause analyses) that arise during validation projects.
- Actively participating in problem solving and identifying opportunities for improvement to optimise validation activities.
- Preparing Standard Operating Procedures for processes and equipment in validation projects.
- Preparing and assisting in internal and external regulatory inspections as requested.
- Providing technical advice on validation concepts to project and department team members.

**Location**: Clayton (Melbourne), Victoria

**Salary**: AU$110,038 to AU $119,080pa (pro-rata for part-time) + up to 15.4% superannuation

**Tenure**: Indefinite, Full time

**Reference**: 94708

**To be considered you will need**:
**Essential**
Under CSIRO policy only those who meet all essential criteria can be appointed.
- A relevant science or engineering tertiary qualification; or equivalent.- Demonstrated experience in a regulated environment and knowledge of cGMP with emphasis on qualification and validation principles.
- Demonstrated ability to work with changing priorities and coordinate multiple tasks.
- Project management skills to ensure delivery of qualification/validation projects from end-to-end involving multiple stakeholders.
- Verbal and written communication skills.

**Desirable**
- At least 5 years’ experience in the pharmaceutical manufacturing industry with experience in Equipment Qualification and Process Validation.
- Knowledge of facility qualification requirements for new / modified sites.

For full details about the role please view the Position Description.

**Eligibility**:
Australian/New Zealand Citizens and Australian Permanent Residents Only.

**Flexible Working Arrangements**:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.

**Diversity and Inclusion**:
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.

**About CSIRO**:
At CSIRO Australia's national science agency, we solve the greatest challenges through innovative science and technology. We put the safety and wellbeing of our people above all else and earn trust everywhere because we only deal in facts. We collaborate widely and generously and deliver solutions with real impact.

CSIRO is committed to values-based leadership to inspire performance and unlock the potential of our people.

CSIRO is committed to the safety and wellbeing of all children and you