On Q Recruitment is pleased to exclusively partner with Viral Vector Manufacturing Facility to help build their quality function.
As the organisation builds a world-class facility to deliver cutting-edge viral vector manufacturing solutions to the biopharmaceutical industry, they are currently seeking a Validation Specialist to join their growing team.
About the Role: Reporting to the Validation Manager, this newly created position presents a unique opportunity to contribute to a rapidly expanding company at a pivotal stage and make a significant impact on its future success.
As the Validation Specialist, you will be responsible for developing and executing validation protocols for systems, equipment, and manufacturing processes within a GMP-regulated environment.
This critical role will ensure the facility's systems and processes meet the highest standards of regulatory compliance and operational excellence.
Your key responsibilities: Develop and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes within a new facility.
Conduct risk assessments and ensure compliance with GMP, TGA, and OGTR regulations during the qualification of newly installed systems.
Analyse validation data and prepare detailed reports for both internal and regulatory review.
Support the entire validation lifecycle, including requalification and periodic reviews of critical systems.
Collaborate with cross-functional teams, including Engineering, Quality, and Operations, to optimise systems and resolve issues.
Maintain inspection-readiness by ensuring the facility adheres to regulatory standards and best practices.
Contribute to the development and continuous improvement of quality systems and processes within the organisation.
To be considered for this role, you will have the following qualifications and skills: A degree in engineering, life sciences, or a related field.
At least 4 years of validation experience within a sterile GMP-regulated environment.
Strong knowledge of TGA and other regulatory requirements for sterile manufacturing.
Experience with facility start-up, commissioning, or viral vector manufacturing is highly desirable.
Excellent problem-solving skills and the ability to manage multiple projects in a fast-paced environment.
Strong communication and collaboration skills to work effectively with cross-functional teams.
This is a rare opportunity to join a growing organization at a crucial stage in its development and help build and optimise key processes from the ground up.
For a confidential conversation, please email Grace Bitodi at ******.
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