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Sydney, New South Wales, Australia Kinexus Full timeUnlock Your Potential in Defence EngineeringKinexus, a leading recruitment partner to the Defence Industry in Australia, is seeking a skilled Validation and Verification Engineer to join our team. As a key player in delivering engineering solutions to Defence, you will have the opportunity to work on high-impact projects that shape the future of Defence...
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Sydney, New South Wales, Australia PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team in the life sciences industry. As a CQV Engineer, you will be responsible for ensuring the quality and compliance of our facilities, equipment, and utilities in assigned projects.Key ResponsibilitiesCommission,...
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Commissioning Qualification Validation Specialist
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Sydney, New South Wales, Australia PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our facilities, equipment, and utilities.Key ResponsibilitiesCommission, qualify, and validate GxP facilities, equipment, and...
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Sydney, New South Wales, Australia PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team in the life sciences industry. As a CQV Engineer, you will be responsible for ensuring the quality and compliance of our facilities, equipment, and utilities in assigned projects.Key ResponsibilitiesCommission,...
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Commissioning Qualification Validation Specialist
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Sydney, New South Wales, Australia PSC Biotech Corporation Full timeAbout the RolePSC Biotech Corporation is seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Engineer to join our team. As a CQV Engineer, you will play a critical role in ensuring the quality and compliance of our facilities, equipment, and utilities.Key ResponsibilitiesCommission, qualify, and validate GxP facilities, equipment, and...
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Validation and Verification Specialist
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Sydney, New South Wales, Australia Kinexus Full timeJoin Kinexus in Shaping the Future of Defence Naval OperationsKinexus is Australia's leading supplier of recruitment solutions to the Defence Industry. We are proud to partner with a leading Prime contractor to deliver engineering solutions to Defence.This is an exciting opportunity to work on a high-impact project that will shape the future of Defence naval...
Validation Engineer
2 months ago
We are seeking a highly skilled Validation Engineer to join our client's team in the cell and gene therapy sector. As a key member of the manufacturing team, you will play a crucial role in ensuring the quality and compliance of our products.
Key Responsibilities- Validation Activities: Plan, coordinate, and monitor validation activities associated with changes to existing plant, equipment, and processes.
- Quality Management: Manage validation activities following the Quality Management System, Site Validation Master Plan, Business Improvement, and Validation procedures to meet regulatory requirements.
- Documentation: Prepare, implement, and maintain departmental documentation for validation activities and regulatory submissions.
- Collaboration: Build and maintain collaborative relationships with internal and external partners.
- Audits: Participate in internal and external audits to ensure compliance with regulatory requirements.
- Problem-Solving: Participate in problem-solving and identify opportunities for improvement to optimize validation activities.
- Training: Ensure all training certification requirements are up-to-date.
- CQV Leadership: Provide cGMP leadership and guidance for the integration and delivery of CQV activities within the site.
- Education: Bachelor's degree in Science or Engineering with a major in Chemical Engineering.
- Experience: 5+ years' experience performing commissioning and/or qualification activities in an FDA-regulated industry.
- Skills: Strong knowledge of FDA regulations for viral vector manufacturing, Lean Six Sigma certification, and excellent time management and organizational skills.
