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Validation Engineer
3 weeks ago
About IDT Australia
IDT Australia is an ASX-listed Contract Development and Manufacturing Organisation (CDMO), providing globally recognised, fee-for-service pharmaceutical development and manufacturing services.
With a focus on cancer and mental health therapies, we support the development of novel medicines for clinical trials through R&D, process scale-up, and GMP manufacturing.
We hold both TGA and FDA accreditation and operate uniquely within Victoria and Australia, with specialised capabilities in the development and manufacture of drugs in highly contained sterile facilities for local and international markets.
The Role
We are seeking a Validation Engineer to join our Engineering Department.
This is a critical role ensuring that all equipment, facilities, utilities, and manufacturing processes (including lyophilization) meet stringent engineering and regulatory standards.
The position requires advanced technical expertise and plays a key part in maintaining compliance, optimising operations, and supporting cost-effective and reliable manufacturing outcomes.
Key Responsibilities
Plan, execute, and document validation and qualification activities for equipment, facilities, utilities, and manufacturing processes.
Ensure systems are designed, installed, and operated in line with engineering specifications and regulatory requirements.
Act as site expert for lyophilization and related sterile manufacturing processes.
Maintain regulatory compliance while driving continuous improvement in product quality and manufacturing efficiency.
Support high-priority development and commercial projects through technical problem-solving and validation expertise.
Collaborate across departments to ensure site readiness for inspections and audits.
Skills and Experience
Degree in Engineering, Pharmaceutical Sciences, or a related discipline.
Demonstrated experience in validation engineering within a pharmaceutical GMP environment.
Strong knowledge of validation principles, regulatory requirements, and industry standards (TGA, FDA, ICH, EU GMP).
Hands-on expertise with sterile manufacturing processes and lyophilization preferred.
Proven ability to manage multiple projects with strong attention to detail and documentation practices.
Excellent problem-solving skills and ability to work effectively within cross-functional teams.
Must have full working rights within Australia.
A police check and employment medical will be required.
